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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Date	Product	Reason	Class	Firm
Feb 28, 2019	Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-3...	CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ...	Class II	Camber Pharmaceuticals Inc
Feb 28, 2019	Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30...	CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ...	Class II	Camber Pharmaceuticals Inc
Feb 25, 2019	Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottle...	Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.	Class II	Macleods Pharma Usa Inc
Feb 25, 2019	Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, ...	Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.	Class II	Macleods Pharma Usa Inc
Feb 25, 2019	Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx...	Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.	Class II	Macleods Pharma Usa Inc
Feb 22, 2019	Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M...	Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du...	Class II	Ascend Laboratories LLC
Feb 21, 2019	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 coun...	CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the...	Class II	Macleods Pharma Usa Inc
Feb 19, 2019	Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05)...	Failed dissolution specifications	Class III	Amerigen Pharmaceuticals Inc.
Feb 15, 2019	Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only,...	Subpotent Drug.	Class II	Heritage Pharmaceuticals, Inc.
Feb 7, 2019	Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Labo...	Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.	Class III	ACP Nimble Buyer, Inc.
Feb 6, 2019	Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottl...	Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.	Class III	Dr. Reddy's Laboratories, Inc.
Jan 31, 2019	Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx ...	Failed Dissolution Specifications: Out of specification results observed for high dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
Jan 30, 2019	Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles...	Failed Dissolution Specifications: high out of specification results for dissolution when measuri...	Class III	Valeant Pharmaceuticals North America LLC
Jan 30, 2019	Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles...	Failed Dissolution Specifications: high out of specification results for dissolution when measuri...	Class III	Valeant Pharmaceuticals North America LLC
Jan 30, 2019	Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles...	Failed Dissolution Specifications: high out of specification results for dissolution when measuri...	Class III	Valeant Pharmaceuticals North America LLC
Jan 30, 2019	Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo...	Failed Dissolution Specifications: high out of specification results for dissolution when measuri...	Class III	Valeant Pharmaceuticals North America LLC
Jan 30, 2019	Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles...	Failed Dissolution Specifications: high out of specification results for dissolution when measuri...	Class III	Valeant Pharmaceuticals North America LLC
Jan 24, 2019	BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distr...	Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.	Class II	Sun Pharmaceutical Industries, Inc.
Jan 18, 2019	Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Prinston Pharmaceutical Inc
Jan 18, 2019	Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Onl...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Prinston Pharmaceutical Inc
Jan 18, 2019	Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Prinston Pharmaceutical Inc
Jan 18, 2019	Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huah...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Prinston Pharmaceutical Inc
Jan 18, 2019	Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactu...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Prinston Pharmaceutical Inc
Jan 15, 2019	Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, M...	Presence of Foreign Substance: Product complaint of black speckles observed on tablets.	Class II	Dr. Reddy's Laboratories, Inc.
Jan 15, 2019	Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, ...	Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated ou...	Class II	LUPIN SOMERSET
Jan 15, 2019	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.	Class II	Tris Pharma Inc.
Jan 15, 2019	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.	Class II	Tris Pharma Inc.
Jan 15, 2019	infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.	Class II	Tris Pharma Inc.
Jan 3, 2019	Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L...	Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid...	Class I	Sun Pharmaceutical Industries, Inc.
Jan 3, 2019	Vecuronium Bromide for Injection 10 mg, 1mg/mL when reconstituted to 10 mL ...	Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid...	Class I	Sun Pharmaceutical Industries, Inc.
Jan 2, 2019	Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ...	Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle	Class II	Heritage Pharmaceuticals, Inc.
Dec 31, 2018	Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurob...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aur...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Auro...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactur...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Auro...	GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only,...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 31, 2018	Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Au...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ...	Class II	Aurobindo Pharma USA Inc.
Dec 26, 2018	LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC...	Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i...	Class III	Sun Pharmaceutical Industries, Inc.
Dec 26, 2018	Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC ...	Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator	Class II	Glenmark Pharmaceuticals Inc., USA
Dec 21, 2018	Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufa...	Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specificat...	Class II	LUPIN SOMERSET
Dec 20, 2018	Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and...	Failed Dissolution Specifications	Class III	Amerigen Pharmaceuticals Inc.

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.