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 II | October 30, 2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag,… | CGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag,… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only,… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 30, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag,… | cGMP violations | Fresenius Kabi Compounding, LLC | Terminated |
| Class II | October 23, 2024 | Dapsone Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd.,… | Crystallization | VIONA PHARMACEUTICALS INC | Ongoing |
| Class II | October 23, 2024 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc | Completed |
| Class II | October 23, 2024 | First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral… | Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral… | Zhejiang Jingwei Pharmaceutical Co., Ltd. | Ongoing |
| Class I | October 23, 2024 | Atovaquone Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by:… | Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. | Bionpharma Inc. | Terminated |
| Class II | October 23, 2024 | Cisplatin Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose… | Failed Impurities/Degradation Specifications. | ACCORD HEALTHCARE, INC. | Terminated |
| Class I | October 16, 2024 | Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No… | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine. | 123Herbals | Ongoing |
| Class III | October 9, 2024 | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm… | Defective Container: Firm received complaints of broken tube at the seal. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | October 9, 2024 | Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30,… | Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and… | Supercore Products Group Inc. | Ongoing |
| Class I | October 9, 2024 | Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199 | Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and… | Supercore Products Group Inc. | Ongoing |
| Class II | October 9, 2024 | Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection,… | CGMP deviations | Advanced Accelerator Applications USA, Inc. | Ongoing |
| Class II | October 9, 2024 | Atorvastatin Calcium Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured… | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle… | Nivagen Pharmaceuticals Inc | Terminated |
| Class I | October 9, 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured… | Presence of Particulate Matter: Presence of glass particle. | Gilead Sciences, Inc. | Terminated |
| Class II | October 9, 2024 | Ryaltris Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg… | Defective Delivery System: The dip tube is clogged causing the spray not to work. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | October 2, 2024 | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For… | Lack of Assurance of Sterility | Empower Pharmacy | Terminated |
| Class II | October 2, 2024 | EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles,… | CGMP deviations | EnviroServe Chemicals Inc. | Ongoing |
| Class II | October 2, 2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt,… | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | AbbVie Inc. | Ongoing |
| Class II | October 2, 2024 | Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules,… | Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen,… | Guru Inc. | Ongoing |
| Class II | October 2, 2024 | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment,… | Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. | AbbVie Inc. | Ongoing |
| Class II | October 2, 2024 | Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%)… | Microbial Contamination of Non-Sterile Product | Vivier Pharma, Inc. | Ongoing |
| Class II | October 2, 2024 | Proparacaine Hydrochloride Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx… | Temperature abuse: Products exposed to improper temperature above drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office | Terminated |
| Class II | October 2, 2024 | Mycophenolic Acid Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle,… | Failed Dissolution Specifications | Ascend Laboratories, LLC | Ongoing |
| Class II | October 2, 2024 | Mupirocin Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals,… | Subpotent Drug | Glenmark Pharmaceuticals Inc., USA | Completed |
| Class III | September 25, 2024 | Acetazolamide AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen… | Discoloration | Rubicon Research Private Limited | Ongoing |
| Class II | September 18, 2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube,… | Microbial contamination of non-sterile Products - | PREQUEL SKIN | Ongoing |
| Class III | September 18, 2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only,… | LABELING: LABEL MIX-UP. | Elevate Oral Care | Terminated |
| Class I | September 11, 2024 | HEPARIN SODIUM IN SODIUM CHLORIDE Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2… | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Baxter Healthcare Corporation | Ongoing |
| Class II | September 11, 2024 | TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton,… | Lack of Assurance of Sterility | ProRx LLC | Ongoing |
| Class II | September 11, 2024 | TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton,… | Lack of Assurance of Sterility | ProRx LLC | Ongoing |
| Class II | September 11, 2024 | Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial,… | Lack of Assurance of Sterility | ProRx LLC | Ongoing |
| Class II | September 11, 2024 | Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx… | Lack of Assurance of Sterility | ProRx LLC | Ongoing |
| Class II | September 11, 2024 | SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded… | Lack of Assurance of Sterility | ProRx LLC | Ongoing |
| Class II | September 11, 2024 | SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd… | Lack of Assurance of Sterility | ProRx LLC | Ongoing |
| Class II | September 11, 2024 | Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx,… | Lack of Assurance of Sterility | ProRx LLC | Ongoing |
| Class II | September 4, 2024 | Ibuprofen IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,… | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively,… | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | September 4, 2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg:… | Failed Impurities/Degradation Specifications - at 18-month Stability testing | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | September 4, 2024 | Ibuprofen IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,… | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively,… | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | September 4, 2024 | Ibuprofen IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,… | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively,… | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | September 4, 2024 | CEFIXIME Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for:… | Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | September 4, 2024 | Indomethacin Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC… | Failed Dissolution Specifications: below specification results | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | August 28, 2024 | ACETAMINOPHEN ASPIRIN AND CAFFEINE Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65… | Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. | Aurobindo Pharma USA Inc | Ongoing |
| Class II | August 28, 2024 | Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron… | Lack of Assurance of Sterility | Fagron Compounding Services | Ongoing |
| Class I | August 28, 2024 | Acetaminophen Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For… | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap… | Hikma Pharmaceuticals USA Inc. | Ongoing |
| Class I | August 28, 2024 | SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical… | Presence of Particulate Matter | B. Braun Medical Inc | Ongoing |
| Class II | August 28, 2024 | testosterone Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva… | Superpotent Drug | Teva Pharmaceuticals USA, Inc | Ongoing |
| Class II | August 28, 2024 | HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L… | CGMP Deviations: sterile water not used for production | Zeco LLC | Completed |
| Class II | August 28, 2024 | timolol maleate Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC… | Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in… | FDC Limited | Ongoing |
| Class II | August 28, 2024 | Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L… | CGMP Deviations: sterile water not used for production | Zeco LLC | Completed |
| Class III | August 21, 2024 | Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro… | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly… | Taro Pharmaceuticals U.S.A., Inc. | Completed |
| Class II | August 21, 2024 | timolol maleate Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,… | Defective container; yellow colored spike from cap lodged in the nozzle | FDC Limited | Ongoing |
| Class I | August 14, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count… | Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole. | MAIN PRODUCTS INC | Ongoing |
| Class II | August 14, 2024 | Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial,… | Lack of Assurance of Sterility | EMPOWER CLINIC SERVICES LLC | Terminated |
| Class II | August 14, 2024 | Gabapentin Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules… | Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets | Granules Pharmaceuticals Inc. | Terminated |
| Class III | August 14, 2024 | PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and… | Defective container: potential for non-sealed pouches which can lead to product leakage. | Novel Laboratories, Inc. d.b.a Lupin Somerset | Terminated |
| Class I | August 14, 2024 | Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S… | Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the… | A-S Medication Solutions LLC | Terminated |
| Class III | August 14, 2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release… | Label mix-up: Carton incorrectly labeled. | Granules Consumer Health Inc. | Terminated |
| Class III | August 14, 2024 | Sevelamer Carbonate for Oral Suspension Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per… | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class III | August 14, 2024 | Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal… | Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate… | Amneal Pharmaceuticals, LLC | Completed |
| Class II | August 7, 2024 | PROGESTERONE Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx… | Presence of Particulate Matter: Complaint received of a glass particle in the vial. | Eugia US LLC | Ongoing |
| Class I | August 7, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count… | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and… | SoloVital | Ongoing |
| Class II | August 7, 2024 | Ciprofloxacin Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC… | Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of… | FDC Limited | Ongoing |
| Class I | August 7, 2024 | Potassium Chloride Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle… | Failed Dissolution Specifications | Amerisource Health Services LLC | Ongoing |
| Class II | August 7, 2024 | azelaic acid Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark… | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | August 7, 2024 | CLONAZEPAM Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10… | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The… | Endo Pharmaceuticals, Inc. | Terminated |
| Class III | July 31, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global… | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | GLOBAL WIDGET LLC | Ongoing |
| Class III | July 31, 2024 | Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles,… | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | GLOBAL WIDGET LLC | Ongoing |
| Class III | July 31, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global… | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | GLOBAL WIDGET LLC | Ongoing |
| Class III | July 31, 2024 | Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic… | Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C. | Washington Homeopathic Products, Inc. | Terminated |
| Class III | July 31, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global… | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | GLOBAL WIDGET LLC | Ongoing |
| Class II | July 31, 2024 | Venlafaxine Hydrochloride Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count… | Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and… | Zydus Pharmaceuticals (USA) Inc | Terminated |
| Class II | July 24, 2024 | Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in… | Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination | Brands International Corporation | Ongoing |
| Class II | July 24, 2024 | Potassium Chloride Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle,… | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | July 24, 2024 | Potassium Chloride Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle,… | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | July 24, 2024 | Potassium Chloride Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle,… | CGMP Deviations | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | July 24, 2024 | Potassium Chloride Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle,… | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | July 24, 2024 | PRAVASTATIN SODIUM Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90;… | Failed Dissolution Specifications: results below specifications | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | July 24, 2024 | Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister… | CGMP Deviations: Out of specification for dissolution | RemedyRepack Inc. | Terminated |
| Class II | July 24, 2024 | Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in… | Failed Impurities/Degradation Specifications | Viatris Inc | Completed |
| Class II | July 24, 2024 | Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in… | Failed Impurities/Degradation Specifications | Viatris Inc | Completed |
| Class II | July 24, 2024 | Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured… | Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown… | Teva Pharmaceuticals USA, Inc | Ongoing |
| Class II | July 24, 2024 | Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only,… | Presence of particulate matter: glass | Zydus Pharmaceuticals (USA) Inc | Terminated |
| Class II | July 24, 2024 | Nitrofurantion Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle,… | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | July 24, 2024 | STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml),… | Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism | Homeocare Laboratories, Inc. | Terminated |
| Class I | July 24, 2024 | STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by:… | Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms | Homeocare Laboratories, Inc. | Terminated |
| Class II | July 24, 2024 | DELFLEX DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and… | This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to… | Fresenius Medical Care Holdings, Inc. | Ongoing |
| Class II | July 17, 2024 | Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube… | CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. | Equibal Inc | Terminated |
| Class I | July 17, 2024 | suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum… | Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) | SYNCHRONICITY SPA INC, DBA SUNTE | Ongoing |
| Class II | July 17, 2024 | Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml… | Subpotent Drug: reduced efficacy for epinephrine | TAILSTORM HEALTH INC | Ongoing |
| Class III | July 17, 2024 | diflorasone diacetate Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne… | Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to… | Rising Pharma Holding, Inc. | Ongoing |
| Class II | July 17, 2024 | suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad… | CGMP Deviations | SYNCHRONICITY SPA INC, DBA SUNTE | Ongoing |
| Class III | July 17, 2024 | Verapamil Hydrochloride Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial… | Cross contamination with other products. | Zydus Pharmaceuticals (USA) Inc | Ongoing |
| Class III | July 17, 2024 | Verapamil Hydrochloride Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL… | Cross contamination with other products. | Zydus Pharmaceuticals (USA) Inc | Ongoing |
| Class II | July 17, 2024 | bupropion hydrochloride buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets… | Failed Dissolution Specifications; the product is dissolving faster than the specified limits. | Amerisource Health Services LLC | Ongoing |
| Class III | July 17, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for:… | Cross contamination with other products | Zydus Pharmaceuticals (USA) Inc | Completed |
| Class III | July 17, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by:… | Cross contamination with other products | Zydus Pharmaceuticals (USA) Inc | Completed |
| Class II | July 17, 2024 | DIANEAL LOW CALCIUM WITH DEXTROSE Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For… | Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. | Baxter Healthcare Corporation | Ongoing |
| Class II | July 10, 2024 | Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent,… | CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine… | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing |
| Class I | July 10, 2024 | RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box… | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Integrity Products | Ongoing |
| Class I | July 10, 2024 | To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count… | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Integrity Products | Ongoing |
| Class II | July 10, 2024 | Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder,… | CGMP Deviations and Presence of Particulate Matter: Glass | Medisca Inc. | Completed |
| Class II | July 10, 2024 | Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G),… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class II | July 10, 2024 | Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class II | July 10, 2024 | Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML)… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class II | July 10, 2024 | Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class II | July 10, 2024 | Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G)… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class II | July 10, 2024 | Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as:… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class II | July 10, 2024 | Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class III | July 10, 2024 | Eszopiclone Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's… | Failed Impurities/Degradation Specifications: Related Substances | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | July 10, 2024 | Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a)… | CGMP deviations | Little Moon Essentials LLC | Ongoing |
| Class II | July 10, 2024 | Methylphenidate Hydrochloride Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx… | Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution… | Trigen Laboratories | Terminated |
| Class II | July 10, 2024 | Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card… | Failed dissolution specifications: out of specification result obtained during routine stability testing for high… | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class III | July 10, 2024 | Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx… | Subpotent drug: out of specification results | Accord Healthcare, Inc. | Terminated |
| Class II | July 10, 2024 | Allopurinol Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr.… | Presence of foreign substance. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | July 3, 2024 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per… | Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C… | PACIRA PHARMACEUTICALS INC | Ongoing |
| Class II | July 3, 2024 | Labetalol Hydrochloride Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject,… | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Pfizer Inc. | Ongoing |
| Class II | July 3, 2024 | Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR… | Discoloration: Brownish tablets | Contract Pharmacal Corporation | Ongoing |
| Class II | July 3, 2024 | Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject,… | Lack of Assurance of Sterility-The potential for incomplete crimp seals. | Pfizer Inc. | Ongoing |
| Class II | July 3, 2024 | Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet… | Presence of Foreign Substance; Broken metal piece found embedded in tablet. | Coast Quality Pharmacy, LLC dba Anazao Health | Completed |
| Class III | July 3, 2024 | SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant… | Sub-potent Drug | Neilmed Pharmaceuticals Inc | Ongoing |
| Class II | July 3, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC… | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the… | Golden State Medical Supply Inc. | Terminated |
| Class II | June 26, 2024 | Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL)… | cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. | Denison Pharmaceuticals, LLC | Terminated |
| Class III | June 26, 2024 | eptifibatide Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India… | Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer. | Eugia US LLC | Ongoing |
| Class II | June 26, 2024 | OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count… | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and… | MexHealth LLC | Ongoing |
| Class II | June 26, 2024 | Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles,… | Subpotent Drug | Teva Pharmaceuticals USA, Inc | Ongoing |
| Class II | June 26, 2024 | Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL… | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were… | Eugia US LLC | Ongoing |
| Class II | June 26, 2024 | Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following… | Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar… | Consumer Product Partners, LLC | Terminated |
| Class II | June 26, 2024 | CEFIXIME Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral… | Failed Content Uniformity Specifications | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | June 26, 2024 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc | Terminated |
| Class II | June 19, 2024 | Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class II | June 19, 2024 | Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL,… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class I | June 19, 2024 | Docetaxel Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx… | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Sagent Pharmaceuticals | Ongoing |
| Class I | June 19, 2024 | Docetaxel Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx… | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Sagent Pharmaceuticals | Ongoing |
| Class III | June 19, 2024 | Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30… | Defective Container | Organon Llc | Ongoing |
| Class II | June 19, 2024 | Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by:… | Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. | RemedyRepack Inc. | Terminated |
| Class II | June 19, 2024 | Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by:… | Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. | Winder Laboratories, LLC | Completed |
| Class II | June 19, 2024 | Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable… | Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. | PACIRA PHARMACEUTICALS INC | Ongoing |
| Class III | June 19, 2024 | ASMANEX Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60… | Defective Container | Organon Llc | Ongoing |
| Class III | June 19, 2024 | ASMANEX Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14… | Defective Container | Organon Llc | Ongoing |
| Class II | June 12, 2024 | Rizatriptan Benzoate Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose… | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class III | June 12, 2024 | Cephalexin Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each… | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g'… | Bryant Ranch Prepack, Inc. | Ongoing |
| Class III | June 12, 2024 | Estradiol Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by:… | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc | Ongoing |
| Class III | June 12, 2024 | Estradiol Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by:… | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc | Ongoing |
| Class II | June 12, 2024 | Rizatriptan Benzoate Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for:… | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | June 12, 2024 | Rizatriptan Benzoate Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for:… | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | June 12, 2024 | Rizatriptan Benzoate Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose… | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class III | June 12, 2024 | Cephalexin Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each… | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g'… | Bryant Ranch Prepack, Inc. | Ongoing |
| Class III | June 12, 2024 | Cephalexin Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by:… | Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet… | Bryant Ranch Prepack, Inc. | Ongoing |
| Class III | June 12, 2024 | Cephalexin Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each… | Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g'… | Bryant Ranch Prepack, Inc. | Ongoing |
| Class III | June 12, 2024 | Pregabalin Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma… | Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a… | Rising Pharma Holding, Inc. | Ongoing |
| Class III | June 12, 2024 | Tivicay Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, Each carton… | Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct… | GlaxoSmithKline LLC | Terminated |
| Class III | June 12, 2024 | Cephalexin Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each… | Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on… | Bryant Ranch Prepack, Inc. | Ongoing |
| Class II | June 5, 2024 | EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL… | Lack of Assurance of Sterility: Complaints of syringe breakage | Regeneron Pharmaceuticals Inc | Terminated |
| Class II | June 5, 2024 | Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class II | June 5, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%),… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class II | June 5, 2024 | Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL),… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class II | June 5, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%),… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class II | June 5, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class II | June 5, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%),… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate… | Out of Specification for active ingredient | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate… | Out of Specification for active ingredient | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad… | Out of Specification for active ingredient | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%),… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular… | Lack of Assurance of Sterility | Imprimis NJOF, LLC | Ongoing |
| Class I | June 5, 2024 | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a… | Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate | Revive Rx LLC dba Revive Rx Pharmacy | Ongoing |
| Class II | June 5, 2024 | NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with… | Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process. | ARG Laboratories, Inc. | Ongoing |
| Class II | June 5, 2024 | Metoprolol Tartrate Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by:… | Presence of Foreign Substance: metal in tablet | Rubicon Research Private Limited | Ongoing |
| Class II | June 5, 2024 | Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA… | Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. | Genentech, Inc. | Terminated |
| Class II | June 5, 2024 | Cefdinir Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only,… | Defective container: lack of seal integrity. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | June 5, 2024 | Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only,… | Lack of Assurance of Sterility: Leaking vials | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | May 29, 2024 | Haloperidol Decanoate Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC… | Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). | SOMERSET THERAPEUTICS LLC | Ongoing |
| Class III | May 29, 2024 | Sirolimus Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's… | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | May 29, 2024 | Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class I | May 29, 2024 | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL… | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. | Hikma Injectables USA Inc | Completed |
| Class II | May 29, 2024 | nicardipine hydrochloride niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose… | Lack of Assurance of Sterility. | American Regent, Inc. | Terminated |
| Class III | May 29, 2024 | Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only,… | Failed Release Testing: Out of specification for particulate matter test. | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing |
| Class II | May 29, 2024 | Vasopressin Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose… | Subpotent product in addition to having out-of-specification results for impurities. | American Regent, Inc. | Terminated |
| Class II | May 22, 2024 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl.… | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Pharma Nobis LLC | Ongoing |
| Class II | May 22, 2024 | Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon… | cGMP Deviations | Dercher Enterprises, Inc., DBA Gordon Laboratories | Completed |
| Class I | May 22, 2024 | Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by… | Marketed Without An Approved NDA/ANDA | Stop Clopez Corp | Terminated |
| Class II | May 22, 2024 | Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl.… | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Pharma Nobis LLC | Ongoing |
| Class II | May 22, 2024 | Cefdinir Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx… | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | May 22, 2024 | Cefdinir Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx… | Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | May 22, 2024 | Methylprednisolone acetate MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1… | Presence of Particulate Matter: Potential for black particulates in the drug product. | Sagent Pharmaceuticals | Ongoing |
| Class II | May 22, 2024 | losartan potassium and hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle,… | Presence of foreign substance: plastic-like substance. | MACLEODS PHARMA USA, INC | Ongoing |
| Class II | May 15, 2024 | Amphotericin B Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun… | Out of specification for assay | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing |
| Class II | May 15, 2024 | Clorazepate Dipotassium Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC… | Discoloration: Dotted and yellow spots on tablets | Aurobindo Pharma USA Inc. | Ongoing |
| Class II | May 15, 2024 | Clorazepate Dipotassium Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC… | Discoloration: Dotted and yellow spots on tablets | Aurobindo Pharma USA Inc. | Ongoing |
| Class I | May 15, 2024 | Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per… | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | May 15, 2024 | TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b)… | Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen… | RemedyRepack Inc. | Terminated |
| Class I | May 15, 2024 | JAVYGTOR Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual… | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | May 15, 2024 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc | Ongoing |
| Class II | May 15, 2024 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc | Ongoing |
| Class II | May 15, 2024 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by:… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc | Ongoing |
| Class II | May 15, 2024 | Tramadol Hydrochloride traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by:… | Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol | Rubicon Research Private Limited | Ongoing |
| Class III | May 15, 2024 | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle,… | Subpotent drug | Acella Pharmaceuticals, LLC | Terminated |
| Class II | May 15, 2024 | timolol maleate Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC… | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from… | FDC Limited | Terminated |
| Class II | May 8, 2024 | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%,… | Subpotent Drug | Imprimis NJOF, LLC | Ongoing |
| Class III | May 8, 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use… | Out of specification for assay | Imprimis NJOF, LLC | Ongoing |
| Class III | May 8, 2024 | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL… | Labeling: Wrong Barcode | Hikma Injectables USA Inc | Completed |
| Class II | May 8, 2024 | Methylergonovine Maleate Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by:… | Failed Dissolution Specifications | Amneal Pharmaceuticals of New York, LLC | Completed |
| Class III | May 8, 2024 | Valacyclovir Hydrochloride Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan… | Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets. | Viatris Inc | Completed |
| Class II | May 8, 2024 | EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose… | Lack of Assurance of Sterility: Complaints of syringe breakage | Regeneron Pharmaceuticals Inc | Terminated |
| Class II | May 1, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx… | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… | EPI Health, LLC | Terminated |
| Class I | May 1, 2024 | ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister… | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA… | FA Online Inc | Terminated |
| Class I | May 1, 2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,… | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. | Ongoing |
| Class I | May 1, 2024 | HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class II | May 1, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100… | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not… | Nomax Inc | Ongoing |
| Class II | May 1, 2024 | FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300… | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not… | Nomax Inc | Ongoing |
| Class I | May 1, 2024 | libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl… | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. | Ongoing |
| Class I | May 1, 2024 | Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1… | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class II | May 1, 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100… | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not… | Nomax Inc | Ongoing |
| Class II | May 1, 2024 | FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton,… | Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not… | Nomax Inc | Ongoing |
| Class I | May 1, 2024 | Samurai-X Honey 6800, UPC 2 56891 27553 3. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130… | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class I | May 1, 2024 | SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. | Ongoing |
| Class III | May 1, 2024 | ABILIFY Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka… | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. | Ongoing |
| Class II | May 1, 2024 | Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g,… | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… | EPI Health, LLC | Terminated |
| Class II | May 1, 2024 | minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx… | CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… | EPI Health, LLC | Terminated |
| Class II | May 1, 2024 | Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per… | CGMP Deviations | HONEYWELL INC | Terminated |
| Class III | May 1, 2024 | ABILIFY Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka… | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. | Ongoing |
| Class III | May 1, 2024 | ABILIFY Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13)… | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. | Ongoing |
| Class III | May 1, 2024 | ABILIFY Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka… | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. | Ongoing |
| Class II | May 1, 2024 | Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100… | Failed Dissolution Specifications | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | May 1, 2024 | Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL… | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. | Cipla USA, Inc. | Terminated |
| Class I | April 24, 2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx… | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | AvKARE | Terminated |
| Class III | April 24, 2024 | Digoxin Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by:… | Failed Impurities/Degradation Specifications | Novitium Pharma LLC | Terminated |
| Class I | April 24, 2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL… | Superpotent Drug: Due to overfilling of drug powder | Amneal Pharmaceuticals of New York, LLC | Terminated |
| Class II | April 24, 2024 | S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging… | Failed Stability Specifications | Specialty Process Labs LLC | Completed |
| Class II | April 24, 2024 | S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only,… | Failed Stability Specifications | Specialty Process Labs LLC | Completed |
| Class III | April 24, 2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only,… | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. | Esperion | Completed |
| Class II | April 24, 2024 | Humalog Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR… | CGMP Deviations | Eli Lilly & Company | Completed |