Browse Drug Recalls

2,097 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,097 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,097 FDA drug recalls in NJ.

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DateProductReasonClassFirm
Jan 29, 2025 Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured f... CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class II Glenmark Pharmaceuticals Inc., USA
Jan 29, 2025 Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured f... CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class II Glenmark Pharmaceuticals Inc., USA
Jan 29, 2025 Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured f... CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class II Glenmark Pharmaceuticals Inc., USA
Jan 29, 2025 Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured ... CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class II Glenmark Pharmaceuticals Inc., USA
Jan 29, 2025 Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured f... CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class II Glenmark Pharmaceuticals Inc., USA
Jan 29, 2025 Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured f... CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class II Glenmark Pharmaceuticals Inc., USA
Jan 29, 2025 Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured f... CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Class II Glenmark Pharmaceuticals Inc., USA
Jan 22, 2025 Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) ... CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA... Class II Glenmark Pharmaceuticals Inc., USA
Jan 22, 2025 Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b... CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA... Class II Glenmark Pharmaceuticals Inc., USA
Jan 16, 2025 Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufacture... Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet Class III Appco Pharma LLC
Jan 10, 2025 Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syrin... Failed Stability Specifications - 12-month stability test result for one of the known peptides is... Class II Teva Pharmaceuticals USA, Inc
Dec 30, 2024 Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Dis... CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Dec 30, 2024 Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000... CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Dec 30, 2024 Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30)... CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II Rising Pharma Holding, Inc.
Dec 27, 2024 Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vi... Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. Class II Eugia US LLC
Dec 19, 2024 phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx onl... Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... Class II Hikma Injectables USA Inc
Dec 19, 2024 ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, ... Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... Class II Hikma Injectables USA Inc
Dec 18, 2024 medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... CGMP Deviations Class II Eugia US LLC
Dec 16, 2024 Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufact... Failed Impurities/Degradation Specifications Class III SOMERSET THERAPEUTICS LLC
Dec 12, 2024 Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, M... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, In... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufacture... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma,... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured... CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Class II Ascend Laboratories, LLC
Dec 12, 2024 Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured... CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Class II Ascend Laboratories, LLC
Dec 12, 2024 Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactur... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactur... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufact... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 11, 2024 chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, ... CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per... Class II Glenmark Pharmaceuticals Inc., USA
Dec 11, 2024 chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, M... CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per... Class II Glenmark Pharmaceuticals Inc., USA
Dec 10, 2024 Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah... Crystallization Class II VIONA PHARMACEUTICALS INC
Dec 10, 2024 Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah... Crystallization Class II VIONA PHARMACEUTICALS INC
Dec 6, 2024 Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobi... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebiv... Class II Aurobindo Pharma USA Inc
Nov 22, 2024 Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx On... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 19, 2024 Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Di... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Nov 19, 2024 Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Nov 19, 2024 Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Nov 14, 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 th... Class II Keystone Industries
Nov 14, 2024 Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 m... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 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 th... Class II Keystone Industries
Nov 14, 2024 M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 ... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-D... Labeling: Not Elsewhere Classified - Wrong NDC number Class III Zydus Pharmaceuticals (USA) Inc
Nov 14, 2024 Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Glut... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 m... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 o... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net C... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (2... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manu... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.