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 | March 19, 2025 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by:… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. | Ongoing |
| Class II | March 19, 2025 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by:… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. | Ongoing |
| Class I | March 19, 2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS,… | Presence of Particulate Matter | Central Admixture Pharmacy Services, Inc. | Ongoing |
| Class II | March 19, 2025 | Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc… | Chemical Contamination | Johnson, S C and Son, Inc | Ongoing |
| Class II | March 19, 2025 | Chlorambucil Container Description: The product packed in double self-seal cover and… | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. | Ongoing |
| Class II | March 19, 2025 | Alprostadil Container Description: Amber color bottle | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. | Ongoing |
| Class I | March 19, 2025 | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v… | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. | CareFusion 213, LLC | Ongoing |
| Class II | March 19, 2025 | Voriconazole Container Description: voriconazole The product packed in white poly bag… | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. | Ongoing |
| Class II | March 19, 2025 | Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B… | Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 19, 2025 | Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag… | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. | Ongoing |
| Class II | March 19, 2025 | Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. | Ongoing |
| Class II | March 19, 2025 | Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double… | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. | Ongoing |
| Class II | March 19, 2025 | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube,… | Chemical Contamination: Presence of benzene. | Denison Pharmaceuticals, LLC | Ongoing |
| Class III | March 19, 2025 | Livalo Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by:… | Presence of foreign tablets/capsules | Kowa Pharmaceuticals America | Completed |
| Class I | March 19, 2025 | POTASSIUM CHLORIDE POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only,… | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible… | ICU Medical, Inc. | Ongoing |
| Class I | March 19, 2025 | POTASSIUM CHLORIDE POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L,… | Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers… | ICU Medical, Inc. | Ongoing |
| Class II | March 12, 2025 | Nelarabine Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC… | Failed Impurities/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc | Ongoing |
| Class II | March 12, 2025 | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only,… | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC | Ongoing |
| Class II | March 12, 2025 | Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx… | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC | Ongoing |
| Class II | March 12, 2025 | Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby,… | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC | Ongoing |
| Class II | March 12, 2025 | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops,… | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC | Ongoing |
| Class II | March 12, 2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe,… | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC | Ongoing |
| Class II | March 12, 2025 | Nelarabine Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC… | Failed Impurities/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc | Ongoing |
| Class II | March 12, 2025 | Morphine Sulfate Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only,… | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing |
| Class II | March 5, 2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100… | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Wuxi Medical lnstrument Factory Co., Ltd. | Ongoing |
| Class II | March 5, 2025 | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only,… | Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. | Padagis US LLC | Completed |
| Class II | March 5, 2025 | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use… | Lack of Assurance of Sterility: due to a quality control process deviation | Turbare Manufacturing | Completed |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | February 26, 2025 | Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk… | Presence of Particulate Matter. | Provepharm Inc. | Ongoing |
| Class II | February 26, 2025 | Silodosin Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN… | Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low… | AvKARE | Ongoing |
| Class II | February 26, 2025 | fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL… | Lack of Assurance of Sterility | Fagron Compounding Services | Completed |
| Class II | February 26, 2025 | Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),… | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during… | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Ongoing |
| Class II | February 26, 2025 | Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),… | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during… | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class I | February 26, 2025 | Fentanyl system Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in… | Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. | Alvogen, Inc | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),… | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during… | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 26, 2025 | Atomoxetine Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for:… | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 19, 2025 | Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured… | Out of Specification for Dissolution | AvKARE | Ongoing |
| Class I | February 12, 2025 | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL),… | Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿… | ENDO USA, Inc. | Ongoing |
| Class II | February 12, 2025 | Potassium Chloride Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton… | Failed Dissolution Specifications. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Ongoing |
| Class II | February 12, 2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx… | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. | RemedyRepack Inc. | Terminated |
| Class II | February 12, 2025 | HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by… | Failed Impurities/Degradation Specifications | SKY PACKAGING | Ongoing |
| Class II | February 12, 2025 | Carvedilol Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets,… | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 12, 2025 | Carvedilol Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100… | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | February 12, 2025 | GRANIX Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged… | Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the… | Teva Pharmaceuticals USA, Inc | Ongoing |
| Class II | February 12, 2025 | HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only,… | Failed Impurities/Degradation Specifications | SKY PACKAGING | Ongoing |
| Class II | February 12, 2025 | timolol maleate Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,… | 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 III | February 12, 2025 | Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473… | Superpotent; sodium benzoate preservative | PAI Holdings, LLC. dba Pharmaceutical Associates Inc | Terminated |
| Class I | February 5, 2025 | Prograf Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan,… | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Astellas Pharma US Inc. | Ongoing |
| Class III | February 5, 2025 | BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide),… | Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and… | The W.S. Badger Company, Inc. | Terminated |
| Class I | February 5, 2025 | ASTAGRAF XL Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only,… | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Astellas Pharma US Inc. | Ongoing |
| Class II | February 5, 2025 | Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10… | CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA… | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class II | February 5, 2025 | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose… | cGMP Deviations: Product intended for quarantine was inadvertently distributed. | McKesson | Ongoing |
| Class II | January 29, 2025 | Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands… | CGMP Deviations: lack of adequate release testing. | Brands International Corporation | Ongoing |
| Class II | January 29, 2025 | First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt.… | CGMP Deviations; product intended for quarantine was inadvertently distributed | First Aid Beauty Ltd | Ongoing |
| Class I | January 29, 2025 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by… | Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and… | SHOPPERS- PLAZA | Ongoing |
| Class III | January 29, 2025 | Venlafaxine Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco… | Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet | Appco Pharma LLC | Completed |
| Class II | January 22, 2025 | Cardura Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only,… | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during… | Viatris Inc | Terminated |
| Class II | January 22, 2025 | Cardura Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only,… | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during… | Viatris Inc | Terminated |
| Class III | January 22, 2025 | Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured… | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. | Ongoing |
| Class III | January 22, 2025 | Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for:… | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. | Ongoing |
| Class I | January 22, 2025 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for:… | Non-Sterility | Alcon Research LLC | Ongoing |
| Class III | January 22, 2025 | Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron… | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. | Ongoing |
| Class III | January 22, 2025 | Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for:… | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. | Ongoing |
| Class III | January 22, 2025 | Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for:… | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. | Ongoing |
| Class III | January 22, 2025 | Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373… | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. | Ongoing |
| Class III | January 22, 2025 | Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT… | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. | Ongoing |
| Class II | January 22, 2025 | Clobazam Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx… | Presence of Foreign Tablets/Capsules | Amerisource Health Services LLC | Ongoing |
| Class II | January 22, 2025 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx… | Failed Dissolution Specifications: | Amerisource Health Services LLC | Terminated |
| Class II | January 15, 2025 | Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000… | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. | Ongoing |
| Class II | January 15, 2025 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC… | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. | Ongoing |
| Class I | January 15, 2025 | Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong… | Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide,… | Buy-Herbal | Ongoing |
| Class II | January 15, 2025 | Ciprofloxacin Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx… | 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 II | January 15, 2025 | PROGESTERONE Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only,… | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. | Eugia US LLC | Ongoing |
| Class II | January 15, 2025 | Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose… | Failed Stability Specifications | Jubilant Draximage Inc., dba Jubilant Radiopharma | Ongoing |
| Class II | January 15, 2025 | Clobazam Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx… | Presence of Foreign Tablets/Capsules | Amerisource Health Services LLC | Ongoing |
| Class II | January 15, 2025 | Colchicine Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules… | Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30… | Granules Pharmaceuticals Inc. | Terminated |
| Class II | January 15, 2025 | Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by:… | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. | Ongoing |
| Class I | January 15, 2025 | CLONAZEPAM Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per… | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the… | Endo USA, Inc. | Ongoing |
| Class III | January 15, 2025 | Methadone Hydrochloride Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed… | Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only. | West-Ward Columbus Inc | Ongoing |
| Class I | January 15, 2025 | CLONAZEPAM Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton,… | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the… | Endo USA, Inc. | Ongoing |
| Class II | January 15, 2025 | Metformin ER 500 mg Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx… | Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER… | Granules Pharmaceuticals Inc. | Terminated |
| Class II | January 15, 2025 | medroxyprogesterone acetate medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL… | CGMP Deviations | Eugia US LLC | Ongoing |
| Class I | January 15, 2025 | CLONAZEPAM Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per… | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the… | Endo USA, Inc. | Ongoing |
| Class I | January 15, 2025 | CLONAZEPAM Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton… | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the… | Endo USA, Inc. | Ongoing |
| Class II | January 8, 2025 | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma… | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of… | Hikma Injectables USA Inc | Terminated |
| Class II | January 8, 2025 | Dapsone Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad,… | Crystallization | VIONA PHARMACEUTICALS INC | Ongoing |
| Class II | January 8, 2025 | Dapsone Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,… | Crystallization | VIONA PHARMACEUTICALS INC | Ongoing |
| Class I | January 8, 2025 | FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO,… | Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone. | GNMart LLC | Ongoing |
| Class III | January 8, 2025 | Atropine Sulfate Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for:… | Failed Impurities/Degradation Specifications | SOMERSET THERAPEUTICS LLC | Terminated |
| Class III | January 8, 2025 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops,… | LABELING: LABEL MIX-UP | AvKARE | Ongoing |
| Class II | January 8, 2025 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM… | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of… | Hikma Injectables USA Inc | Terminated |
| Class II | January 8, 2025 | Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only,… | Failed Dissolution Specifications | AvKARE | Ongoing |
| Class II | January 8, 2025 | Levothyroxine Sodium Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,… | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | January 8, 2025 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ… | LABELING: LABEL MIX-UP | AvKARE | Ongoing |
| Class II | January 1, 2025 | CHLORPROMAZINE HYDROCHLORIDE chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured… | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA… | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 1, 2025 | CHLORPROMAZINE HYDROCHLORIDE chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured… | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA… | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | January 1, 2025 | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC… | CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. | RemedyRepack Inc. | Ongoing |
| Class II | January 1, 2025 | UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 | cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with… | MXBBB | Ongoing |
| Class II | January 1, 2025 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC… | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc | Ongoing |
| Class II | January 1, 2025 | Duloxetine Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC… | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc | Ongoing |
| Class II | January 1, 2025 | Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC | Ongoing |
| Class II | January 1, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles,… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC | Ongoing |
| Class II | January 1, 2025 | Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30… | Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product | Curium US, LLC | Terminated |
| Class II | January 1, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC | Ongoing |
| Class II | January 1, 2025 | Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. | Amerisource Health Services LLC | Ongoing |
| Class II | January 1, 2025 | DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals… | CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the… | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | December 25, 2024 | Dihydroergotamine Mesylate Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx… | Discoloration | Provepharm Inc. | Ongoing |
| Class II | December 25, 2024 | Nebivolol Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma… | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable… | Aurobindo Pharma USA Inc | Ongoing |
| Class II | December 25, 2024 | Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL),… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml),… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz… | CGMP deviations: out of specifications for assay | Apothecus Pharmaceutical Corp. | Ongoing |
| Class II | December 25, 2024 | LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by:… | Lack of Sterility Assurance | Regenerative Processing Plant, LLC | Terminated |
| Class II | December 25, 2024 | Olanzapine Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods… | Failed Impurities/Degradation Specifications | Macleods Pharmaceuticals Ltd | Ongoing |
| Class II | December 25, 2024 | Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml),… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free,… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml),… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL),… | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed… | Keystone Industries | Terminated |
| Class II | December 25, 2024 | PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed… | Lack of Sterility Assurance | Regenerative Processing Plant, LLC | Terminated |
| Class II | December 18, 2024 | timolol maleate Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only,… | 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 II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC… | Superpotent Drug and Subpotent Drug: potency failures obtained | Viatris Inc | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose… | Subpotent and Superpotent Drug | Mylan Institutional, Inc. | Ongoing |
| Class III | December 18, 2024 | Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free… | Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack,… | Biocompatibles UK, Ltd. | Terminated |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit… | Subpotent and Superpotent Drug | Mylan Institutional, Inc. | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit… | Subpotent and Superpotent Drug | Mylan Institutional, Inc. | Ongoing |
| Class III | December 18, 2024 | Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only,… | Failed Impurities/Degradation Specifications | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | December 18, 2024 | Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose… | cGMP Deviations: Temperature excursion | Mckesson Medical-Surgical Inc. Corporate Office | Terminated |
| Class II | December 18, 2024 | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack;… | CGMP Deviations: Released product should have been rejected. | LNK International, Inc. | Terminated |
| Class II | December 18, 2024 | Dabigatran Etexilate Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem… | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit… | Subpotent and Superpotent Drug | Mylan Institutional, Inc. | Ongoing |
| Class II | December 18, 2024 | Dabigatran Etexilate Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem… | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Ascend Laboratories, LLC | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit… | Subpotent and Superpotent Drug | Mylan Institutional, Inc. | Ongoing |
| Class II | December 18, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit… | Subpotent and Superpotent Drug | Mylan Institutional, Inc. | Ongoing |
| Class II | December 11, 2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Rising Pharma Holding, Inc. | Ongoing |
| Class III | December 11, 2024 | Esomeprazole Magnesium Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets,… | Labeling: Not Elsewhere Classified - Wrong NDC number | Zydus Pharmaceuticals (USA) Inc | Ongoing |
| Class II | December 11, 2024 | Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L),… | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated | Ongoing |
| Class II | December 11, 2024 | Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon,… | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated | Ongoing |
| Class II | December 11, 2024 | ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S.… | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated | Ongoing |
| Class I | December 11, 2024 | VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by:… | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC | Ongoing |
| Class II | December 11, 2024 | 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature +… | CGMP Deviations: Inconsistency in the water systems. | Generitech Corporation | Ongoing |
| Class II | December 11, 2024 | boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L),… | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated | Ongoing |
| Class I | December 11, 2024 | PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by:… | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC | Ongoing |
| Class I | December 11, 2024 | ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N… | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC | Ongoing |
| Class II | December 11, 2024 | Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL)… | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated | Ongoing |
| Class II | December 11, 2024 | Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,… | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable… | AvKARE | Ongoing |
| Class II | December 11, 2024 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,… | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable… | AvKARE | Ongoing |
| Class II | December 11, 2024 | MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L),… | cGMP Deviations: Out of specification results for micro in hand soap products. | Midlab Incorporated | Ongoing |
| Class I | December 11, 2024 | ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St.… | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. | Boulla LLC | Ongoing |
| Class II | December 11, 2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04)… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Amerisource Health Services LLC | Ongoing |
| Class II | December 11, 2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,… | CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable… | AvKARE | Ongoing |
| Class II | December 11, 2024 | Venofer Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL… | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. | Ongoing |
| Class II | December 11, 2024 | Venofer Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL… | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. | Ongoing |
| Class II | December 11, 2024 | Sunitinib Malate Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE,… | Labeling: Label Mix-Up | AvKARE | Ongoing |
| Class II | December 11, 2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Amerisource Health Services LLC | Ongoing |
| Class II | December 11, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle,… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Amerisource Health Services LLC | Ongoing |
| Class II | December 11, 2024 | Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx… | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | December 11, 2024 | Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules,… | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | December 11, 2024 | Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules,… | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | December 11, 2024 | Sunitinib Malate Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE,… | Labeling: Label Mix-Up | AvKARE | Ongoing |
| Class II | December 11, 2024 | Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only,… | Subpotent drug | ACCORD HEALTHCARE, INC. | Terminated |
| Class II | December 11, 2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Rising Pharma Holding, Inc. | Ongoing |
| Class II | December 11, 2024 | Venofer Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL… | Presence of Particulate Matter: Potential for glass delamination from the vials. | American Regent, Inc. | Ongoing |
| Class II | December 11, 2024 | Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b)… | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc | Ongoing |
| Class II | December 11, 2024 | Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed… | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit | Rising Pharma Holding, Inc. | Ongoing |
| Class II | December 11, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx… | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | December 11, 2024 | Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b)… | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc | Ongoing |
| Class II | December 11, 2024 | Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b)… | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Aurobindo Pharma USA Inc | Ongoing |
| Class II | December 11, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only,… | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | December 11, 2024 | Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only,… | Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. | Lannett Company Inc. | Terminated |
| Class II | December 11, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx… | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. | Glenmark Pharmaceuticals Inc., USA | Ongoing |
| Class II | December 4, 2024 | THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24,… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet,… | CGMP violations. | Neogen Corporation | Ongoing |
| Class II | December 4, 2024 | JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By:… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for:… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By:… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5,… | cGMP Deviations | JR Watkins | Terminated |
| Class II | December 4, 2024 | ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box,… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box,… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1)… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per… | CGMP violations. | Neogen Corporation | Ongoing |
| Class II | December 4, 2024 | EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | December 4, 2024 | PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6… | cGMP Deviations | Unexo Life Sciences Private Limited | Terminated |
| Class II | November 27, 2024 | Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box,… | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC | Ongoing |
| Class II | November 27, 2024 | Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box,… | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC | Ongoing |
| Class II | November 27, 2024 | Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box,… | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC | Ongoing |
| Class II | November 27, 2024 | Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box,… | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC | Ongoing |
| Class II | November 27, 2024 | Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose… | cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. | Safecor Health, LLC | Ongoing |
| Class III | November 27, 2024 | Ibuprofen IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's… | Failed Tablet/Capsule Specifications | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | November 27, 2024 | BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx… | Lack of Sterility Assurance | Tailstorm Health INC | Terminated |
| Class II | November 27, 2024 | XELSTRYM Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30… | Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). | Noven Pharmaceuticals Inc | Ongoing |
| Class II | November 27, 2024 | Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401… | Failed Impurity/Degradation Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class III | November 27, 2024 | Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By… | Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test… | Padagis US LLC | Terminated |
| Class II | November 27, 2024 | Ramipril Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC… | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | November 27, 2024 | Ramipril Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC… | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | November 27, 2024 | Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401… | Failed Impurity/Degradation Specifications | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class II | November 27, 2024 | Lisinopril Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart,… | Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. | Evaric Pharmaceuticals Inc. | Terminated |
| Class II | November 27, 2024 | Ramipril Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC… | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | November 20, 2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for… | Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. | Cipla USA, Inc. | Ongoing |
| Class II | November 20, 2024 | Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition… | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen,… | Trinity Gold Nutrition | Ongoing |
| Class II | November 20, 2024 | Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for… | Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. | Cipla USA, Inc. | Ongoing |
| Class III | November 20, 2024 | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet… | Failed Impurities/Degradation Specifications; during routine stability testing for impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Terminated |
| Class II | November 20, 2024 | Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt.… | Subpotent Drug | Keystone Industries | Ongoing |
| Class II | November 13, 2024 | Dapsone Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd.,… | Crystallization | VIONA PHARMACEUTICALS INC | Ongoing |
| Class II | November 13, 2024 | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg,… | Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. | Direct Rx | Ongoing |
| Class II | November 13, 2024 | Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only,… | Failed Impurities/Degradation Specification | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class III | November 13, 2024 | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg),… | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the… | Denison Pharmaceuticals, LLC | Ongoing |
| Class II | November 13, 2024 | Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured… | Failed Impurities/Degradation Specification | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class I | November 13, 2024 | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only,… | Presence of Particulate Matter: Presence of glass particulates. | Staska Pharmaceuticals, Inc. | Terminated |
| Class III | November 13, 2024 | Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100… | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the… | Denison Pharmaceuticals, LLC | Ongoing |
| Class II | November 13, 2024 | Regadenoson Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx… | Labeling: Missing Label | Baxter Healthcare Corporation | Ongoing |
| Class II | November 13, 2024 | timolol maleate Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,… | 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 II | November 6, 2024 | CINACALCET Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc,… | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | November 6, 2024 | CINACALCET Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc,… | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | November 6, 2024 | CINACALCET Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc,… | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Dr. Reddy's Laboratories, Inc. | Ongoing |
| Class II | November 6, 2024 | Cinacalcet Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90… | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI)… | ACCORD HEALTHCARE, INC. | Ongoing |
| Class II | November 6, 2024 | Cinacalcet Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90… | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI)… | ACCORD HEALTHCARE, INC. | Ongoing |
| Class II | November 6, 2024 | Cinacalcet Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90… | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI)… | ACCORD HEALTHCARE, INC. | Ongoing |
| Class II | November 6, 2024 | Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's… | Superpotent Drug: Stability failure for assay at 6 months test time-point. | BLI International, Inc. | 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 30, 2024 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg | Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and… | C & A Naturistics | Ongoing |
| Class II | October 30, 2024 | OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL… | CGMP Deviations | Akron Pharma, Inc. | Ongoing |