Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class III | November 11, 2020 | Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack,… | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. | Terminated |
| Class II | November 11, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per… | Denton Pharma, Inc. | Ongoing |
| Class II | November 11, 2020 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per… | Direct Rx | Terminated |
| Class III | November 11, 2020 | Childrens Ibuprofen Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain… | Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. | Aurobindo Pharma USA Inc. | Terminated |
| Class II | November 11, 2020 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City,… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per… | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | November 11, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only.… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Nostrum Laboratories Inc | Ongoing |
| Class II | November 11, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only.… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Nostrum Laboratories Inc | Ongoing |
| Class II | November 11, 2020 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited | Terminated |
| Class II | November 11, 2020 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level | Marksans Pharma Limited | Terminated |
| Class II | November 11, 2020 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC:… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per… | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | November 4, 2020 | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist.… | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. | Terminated |
| Class II | November 4, 2020 | Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only,… | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per… | RemedyRepack Inc. | Terminated |
| Class II | November 4, 2020 | N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED… | Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap. | Jarrow Formulas Inc | Terminated |
| Class II | November 4, 2020 | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside… | SUBPOTENT DRUG | Bausch Health Companies, Inc. | Terminated |
| Class II | November 4, 2020 | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist.… | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. | Terminated |
| Class II | November 4, 2020 | Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist.… | An extraneous peak was observed for dissolution testing. | Boehringer Ingelheim Pharmaceuticals, Inc. | Terminated |
| Class III | October 28, 2020 | Desflurane Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui… | DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. | eVenus Pharmaceutical Laboratories | Terminated |
| Class II | October 28, 2020 | Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala,… | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand… | Genesis Partnership Company SA | Ongoing |
| Class II | October 28, 2020 | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL)… | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand… | Genesis Partnership Company SA | Ongoing |
| Class II | October 28, 2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by… | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62%… | Genesis Partnership Company SA | Ongoing |
| Class II | October 28, 2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by… | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62%… | Genesis Partnership Company SA | Ongoing |
| Class II | October 28, 2020 | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.)… | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand… | Genesis Partnership Company SA | Ongoing |
| Class III | October 28, 2020 | candesartan cilexetil and hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a)… | Out-of-specification organic impurity results obtained during routine stability testing. | Mylan Pharmaceuticals Inc. | Terminated |
| Class III | October 28, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. | Terminated |
| Class I | October 28, 2020 | NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only,… | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion… | Acella Pharmaceuticals, LLC | Terminated |
| Class III | October 28, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. | Terminated |
| Class I | October 28, 2020 | NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only,… | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion… | Acella Pharmaceuticals, LLC | Terminated |
| Class III | October 28, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. | Terminated |
| Class III | October 28, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. | Terminated |
| Class III | October 28, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. | Terminated |
| Class III | October 28, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. | ANI Pharmaceuticals, Inc. | Terminated |
| Class I | October 21, 2020 | Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as… | Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and… | ASHTEL STUDIOS, INC. | Terminated |
| Class III | October 21, 2020 | CYSTARAN Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle,… | Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. | Leadiant Biosciences, Inc. | Terminated |
| Class II | October 14, 2020 | Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc.… | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Calvin Scott & Company, Inc. | Terminated |
| Class II | October 14, 2020 | Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct… | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… | Direct Rx | Terminated |
| Class II | October 14, 2020 | Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc.… | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Calvin Scott & Company, Inc. | Terminated |
| Class II | October 14, 2020 | Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx… | CGMP Deviations: Presence of NDMA impurity detected in product. | Direct Rx | Terminated |
| Class III | October 14, 2020 | Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for:… | Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability… | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Terminated |
| Class II | October 14, 2020 | Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90)… | CGMP Deviations: Presence of NDMA impurity detected in product. | Direct Rx | Terminated |
| Class II | October 14, 2020 | Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc.… | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Calvin Scott & Company, Inc. | Terminated |
| Class II | October 14, 2020 | Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine… | CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same… | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class III | October 14, 2020 | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum… | Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot | VistaPharm, Inc. | Terminated |
| Class I | October 7, 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea… | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for… | 4e Brands North America, Llc | Terminated |
| Class II | October 7, 2020 | Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL… | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol… | 4e Brands North America, Llc | Terminated |
| Class I | October 7, 2020 | Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2%… | Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label. | Volu-Sol, Inc. | Terminated |
| Class III | October 7, 2020 | Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes,… | Subpotent Drug | Arbor Pharmaceuticals Inc. | Terminated |
| Class II | October 7, 2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged… | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol… | 4e Brands North America, Llc | Terminated |
| Class II | October 7, 2020 | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL… | CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | October 7, 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea… | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol… | 4e Brands North America, Llc | Terminated |
| Class I | October 7, 2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged… | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for… | 4e Brands North America, Llc | Terminated |
| Class II | October 7, 2020 | blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl.… | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol… | 4e Brands North America, Llc | Terminated |
| Class II | October 7, 2020 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville,… | CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API. | Direct Rx | Terminated |
| Class II | October 7, 2020 | pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box,… | Marketed without an Approved NDA/ANDA. | pH-D Feminine Health | Terminated |
| Class II | October 7, 2020 | Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL,… | CGMP Deviations | Akorn, Inc. | Terminated |
| Class I | October 7, 2020 | blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as… | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for… | 4e Brands North America, Llc | Terminated |
| Class II | October 7, 2020 | ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8… | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol… | 4e Brands North America, Llc | Terminated |
| Class III | October 7, 2020 | Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured… | Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles. | Legacy Pharmaceutical Packaging LLC | Terminated |
| Class II | October 7, 2020 | ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8… | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol… | 4e Brands North America, Llc | Terminated |
| Class II | October 7, 2020 | blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a)… | CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol… | 4e Brands North America, Llc | Terminated |
| Class III | October 7, 2020 | Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton,… | Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian… | P & L Developments, LLC | Terminated |
| Class II | October 7, 2020 | Potassium Chloride Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100… | Failed Dissolution Specifications | Strides Inc. | Terminated |
| Class II | October 7, 2020 | Buprenorphine Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per… | Failed Stability Specifications: Below specification result for buprenorphine release rate. | Teva Pharmaceuticals USA | Terminated |
| Class I | September 30, 2020 | Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with… | Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the… | The Protein Shoppe | Terminated |
| Class II | September 30, 2020 | bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en… | CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product. | AJR TRADING LLC | Terminated |
| Class I | September 30, 2020 | Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs,… | Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug… | CORGIOMED LLC | Terminated |
| Class II | September 30, 2020 | Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3)… | CGMP Deviations | Preferred Pharmaceuticals, Inc. | Terminated |
| Class II | September 30, 2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by:… | cGMP Deviations | GRUPO YACANA MEXICO SAS DE CV | Terminated |
| Class II | September 30, 2020 | Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3)… | CGMP Deviations | Preferred Pharmaceuticals, Inc. | Terminated |
| Class II | September 30, 2020 | Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3)… | CGMP Deviations | Preferred Pharmaceuticals, Inc. | Terminated |
| Class II | September 30, 2020 | Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3)… | CGMP Deviations | Preferred Pharmaceuticals, Inc. | Terminated |
| Class II | September 30, 2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by:… | cGMP Deviations | GRUPO YACANA MEXICO SAS DE CV | Terminated |
| Class I | September 30, 2020 | Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9%… | Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol. | Incredible Products, SA de CV | Terminated |
| Class II | September 30, 2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz… | GMP Deviations: Potential to contain 1-propanol. | Nanomateriales Sa De Cv | Terminated |
| Class II | September 30, 2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles,… | GMP Deviations: Potential to contain 1-propanol. | Nanomateriales Sa De Cv | Terminated |
| Class II | September 30, 2020 | Albuterol Sulfate Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations,… | Defective Delivery System: Sustained trend of failure to dispense complaints. | Perrigo Company PLC | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed… | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol.… | Real Clean Distribuciones SA de CV | Terminated |
| Class II | September 23, 2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a)… | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol.… | Real Clean Distribuciones SA de CV | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets,… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg,… | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets,… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products,… | Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various… | Maison Terre, LLC | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg],… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL,… | CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found… | Real Clean Distribuciones SA de CV | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg],… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine… | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg,… | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg],… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500… | Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained… | Real Clean Distribuciones SA de CV | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg],… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg,… | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg],… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine… | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4)… | Subpotent Drug: FDA analysis found product to be subpotent | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%),… | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol.… | Real Clean Distribuciones SA de CV | Terminated |
| Class II | September 23, 2020 | Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg],… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets,… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class II | September 23, 2020 | WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets,… | CGMP Deviations: manufactured under the same conditions as those found to be subpotent. | RLC Labs Inc. | Terminated |
| Class I | September 23, 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl.… | Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for… | Broncolin, S.A. de C.V. | Terminated |
| Class II | September 23, 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as a) 4.22 fl.… | CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to… | Broncolin, S.A. de C.V. | Terminated |
| Class III | September 23, 2020 | Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only,… | Short Fill | Exela Pharma Sciences LLC | Terminated |
| Class II | September 16, 2020 | Cephalexin Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use… | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or… | Teva Pharmaceuticals USA | Terminated |
| Class II | September 16, 2020 | Cephalexin Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use… | Sub-Potent Drug: Out of specification test results for potency (below specification). | Teva Pharmaceuticals USA | Terminated |
| Class II | September 16, 2020 | Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single… | Labeling Not Elsewhere Classified: Product labeled to contain methanol | Open Book Extracts | Terminated |
| Class II | September 16, 2020 | Cephalexin Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use… | CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or… | Teva Pharmaceuticals USA | Terminated |
| Class II | September 16, 2020 | Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC… | Labeling Not Elsewhere Classified: Product labeled to contain methanol | Open Book Extracts | Terminated |
| Class II | September 16, 2020 | Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC… | Labeling: Label Error on Declared Strength | Edge Pharma, LLC | Terminated |
| Class II | September 16, 2020 | Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in… | CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol… | Maquiladora Miniara Sa De Cv | Terminated |
| Class I | September 9, 2020 | SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC,… | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC | Terminated |
| Class I | September 9, 2020 | Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA… | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC | Terminated |
| Class I | September 9, 2020 | Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x… | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC | Terminated |
| Class I | September 9, 2020 | SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC,… | Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug | SG24 LLC | Terminated |
| Class II | September 9, 2020 | Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by… | cGMP Deviations | Soluciones Cosmeticas, SA de CV | Terminated |
| Class II | September 9, 2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL),… | CGMP Deviations | AAA Cosmetica, SA de CV | Terminated |
| Class I | September 9, 2020 | amiodarone hydrochloride Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial… | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone… | Mylan Institutional LLC | Terminated |
| Class II | September 9, 2020 | Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle,… | CGMP Deviation: Potential contamination with undeclared methanol. | ROQUE PLAST, S.A. DE C.V. | Terminated |
| Class II | September 9, 2020 | Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9… | cGMP deviations | Laboratorios Jaloma S.A. de C.V. | Terminated |
| Class I | September 9, 2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL),… | Chemical Contamination: Product contains methanol. | AAA Cosmetica, SA de CV | Terminated |
| Class II | September 9, 2020 | UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged in 3 Fluid… | Subpotent drug | Santa Cruz Biotechnology, Inc | Terminated |
| Class II | September 9, 2020 | HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals,… | Labeling: Error on Declared Strength | Grato Holdings, Inc. | Terminated |
| Class II | September 9, 2020 | Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol 70%,… | Labeling Not Elsewhere Classified: Product labeled to contain methanol. | Leiper's Fork Distillery | Terminated |
| Class I | September 9, 2020 | Tranexamic Acid Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC… | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone… | Mylan Institutional LLC | Terminated |
| Class II | September 2, 2020 | Metformin Hydrochloride Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only… | CGMP Deviations | BAYSHORE PHARMACEUTICALS | Terminated |
| Class II | September 2, 2020 | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (200 mL)… | cGMP deviations | RESOURCE RECOVERY & TRADING LLC | Completed |
| Class I | September 2, 2020 | Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx… | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as… | SCA Pharmaceuticals | Terminated |
| Class II | September 2, 2020 | Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%,… | Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. | Yusef Manufacturing Laboratories, LLC | Terminated |
| Class II | September 2, 2020 | Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for:… | Failed Tablet/Capsule Specification; complaint of bulging tablet | Hetero Labs Limited (Unit V) | Terminated |
| Class I | September 2, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx… | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as… | SCA Pharmaceuticals | Terminated |
| Class II | September 2, 2020 | BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 | Failed Impurity /Degradation Specifications | Par Pharmaceutical Inc. | Terminated |
| Class I | September 2, 2020 | Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only,… | Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain… | Medichem S.A. | Terminated |
| Class II | September 2, 2020 | Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab Inc 1 EcoLab… | Discoloration and Presence of Foreign Substance | Ecolab Inc | Terminated |
| Class II | September 2, 2020 | HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal)… | cGMP deviations | RESOURCE RECOVERY & TRADING LLC | Completed |
| Class I | September 2, 2020 | Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only… | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as… | SCA Pharmaceuticals | Terminated |
| Class I | September 2, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only… | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as… | SCA Pharmaceuticals | Terminated |
| Class III | September 2, 2020 | Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7… | Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the… | The Mentholatum Company | Terminated |
| Class II | September 2, 2020 | Buprenorphine Hydrochloride Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use… | Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. | Hikma Pharmaceuticals USA Inc. | Terminated |
| Class I | September 2, 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL),… | Cross Contamination with other products: trace amounts of lidocaine | Fresenius Kabi USA, LLC | Terminated |
| Class II | September 2, 2020 | Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500… | Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the… | Aurobindo Pharma USA Inc. | Terminated |
| Class II | September 2, 2020 | Metformin Hydrochloride Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only… | CGMP Deviations | BAYSHORE PHARMACEUTICALS | Terminated |
| Class I | August 26, 2020 | ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC | Terminated |
| Class II | August 26, 2020 | Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class I | August 26, 2020 | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only,… | Superpotent Drug | Ferring Pharmaceuticals Inc | Terminated |
| Class I | August 26, 2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for:… | Superpotent Drug | Ferring Pharmaceuticals Inc | Terminated |
| Class II | August 26, 2020 | Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by:… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co.,… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc.… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class III | August 26, 2020 | Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg)… | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was… | Ultra Seal Corporation | Terminated |
| Class II | August 26, 2020 | Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by:… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distributed by:… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class I | August 26, 2020 | STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx… | Superpotent Drug | Ferring Pharmaceuticals Inc | Terminated |
| Class II | August 26, 2020 | Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by:… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b)… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott &… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott &… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by:… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque,… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc.… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company,… | Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets,… | Lannett Company, Inc. | Terminated |
| Class II | August 26, 2020 | Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc.… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class III | August 26, 2020 | Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg)… | Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was… | Ultra Seal Corporation | Terminated |
| Class II | August 26, 2020 | Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b)… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class II | August 26, 2020 | Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott &… | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. | Calvin Scott & Company, Inc. | Terminated |
| Class I | August 26, 2020 | ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC | Terminated |
| Class I | August 26, 2020 | BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v… | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | CareFusion 213, LLC | Terminated |
| Class II | August 26, 2020 | Elitek Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S.… | Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability… | Sanofi-Aventis U.S. LLC | Ongoing |
| Class II | August 19, 2020 | Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate… | Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test. | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | August 19, 2020 | Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube,… | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. | Taro Pharmaceuticals U.S.A., Inc. | Terminated |
| Class I | August 19, 2020 | All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by… | Chemical Contamination: Product contains undeclared methanol. | Itech 361 LLC | Terminated |
| Class II | August 19, 2020 | Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc.… | cGMP Deviations. | Eosera, Inc. | Terminated |
| Class II | August 19, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA… | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | SCA Pharmaceuticals | Terminated |
| Class II | August 19, 2020 | NYSTATIN Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz.… | Subpotent drug: Out of specification for assay at the 15-month test interval. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Terminated |
| Class III | August 19, 2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and… | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. | Golden State Medical Supply Inc. | Terminated |
| Class II | August 19, 2020 | Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL)… | cGMP Deviations. | Eosera, Inc. | Terminated |
| Class II | August 19, 2020 | Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL)… | cGMP Deviations. | Eosera, Inc. | Terminated |
| Class II | August 19, 2020 | Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ… | cGMP Deviations. | Eosera, Inc. | Terminated |
| Class II | August 19, 2020 | Lidocaine Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis… | Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton. | Teva Pharmaceuticals USA | Terminated |
| Class III | August 19, 2020 | Leucovorin Calcium Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by:… | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. | West-Ward Columbus Inc | Terminated |
| Class I | August 12, 2020 | Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Dist by: Tasty… | Chemical Contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles,… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Tasty Drops Hemp Oil Extract, Spearmint, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Sweet Mint, 500mg, 1 fl oz (30 ml)… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 FL. OZ (30… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 500 MG CBD, 1 FL OZ (30 ML) bottles,… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Strawberry Creme, 1000mg, 1 fl oz (30 ml)… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class II | August 12, 2020 | VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate… | cGMP deviations | Vilvet Pharmaceuticals Inc. | Terminated |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Vanilla, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bottles,… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt… | Chemical Contamination; product contains elevated levels of lead | Summitt Labs | Terminated |
| Class I | August 12, 2020 | Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL. OZ (30 ML)… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Distributed by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | SP, hemp oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. OZ (30 ML)… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distributed by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For… | Microbial contamination of non-sterile products: positive microbial contamination in product. | Spartan Chemical Co Inc | Terminated |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles, Dist by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist by: MHR… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spearmint,… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 FL OZ (30… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1 FL. OZ… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Made by Hemp 1000MG Hemp Extract, Mojito Lime, 1 OZ (30 ML) bottles, Dist by: MHR… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles,… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ (30 ML)… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl oz (30 ml)… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Recovery Releaf, Pure CBD Oil, Vanilla, 1000MG, 25MG per serving, 1 fl. oz (30 ml)… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Tasty Drops Hemp Oil Extract, Vanilla, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class II | August 12, 2020 | VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic… | cGMP deviations | Vilvet Pharmaceuticals Inc. | Terminated |
| Class I | August 12, 2020 | Made by Hemp 1000MG Hemp Extract, Strawberry Creme, 1 OZ (30 ML) bottles, Dist by: MHR… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class II | August 12, 2020 | Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone… | Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient… | Yusef Manufacturing Laboratories, LLC | Terminated |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Spearmint, 1 FL. OZ bottles, Distributed by:… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles,… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Tasty Drops, Hemp Oil Extract, Berry, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty… | Chemical contamination: product contains elevated levels of undeclared lead. | MICHIGAN HERBAL REMEDIES | Completed |
| Class I | August 12, 2020 | Daptomycin Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured… | Presence of Particulate Matter | Mylan Institutional LLC | Terminated |
| Class II | August 12, 2020 | Fentanyl Citrate Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop… | Lack of Assurance of Sterility; potential loose metal overseal crimp defects. | Pfizer Inc. | Terminated |
| Class I | August 5, 2020 | Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by… | Chemical Contamination: Product contains undeclared methanol. | UVT INC | Terminated |
| Class II | August 5, 2020 | Lisinopril Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur… | Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets… | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | August 5, 2020 | Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave,… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm, 115-02… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class III | August 5, 2020 | Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in… | SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. | Allergan PLC | Terminated |
| Class II | August 5, 2020 | Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, MasterPharm,… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave,… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave,… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles,… | Subpotent Drug: Product was found to be subpotent. Product also has high pH levels | WORLD EVENT PROMOTIONS, LLC | Terminated |
| Class II | August 5, 2020 | Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave,… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-02 Liberty… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave,… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |
| Class II | August 5, 2020 | Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond… | Lack of Processing Controls (lack of assurance of conformity to specifications). | MasterPharm LLC | Terminated |