Browse Drug Recalls

2,101 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,101 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 2,101 FDA drug recalls in NJ.

Clear

Date	Product	Reason	Class	Firm
Aug 17, 2018	Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 13, 2018	Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Livin...	Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of...	Class I	Living Well Remedies, LLC
Aug 2, 2018	Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. R...	Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Tot...	Class III	Dr. Reddy's Laboratories, Inc.
Jul 24, 2018	10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL...	CGMP deviations: Product was released while a hood certification discrepancy was being investigated.	Class II	PharMEDium Services, LLC
Jul 24, 2018	5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in...	CGMP deviations: Product was released while a hood certification discrepancy was being investigated.	Class II	PharMEDium Services, LLC
Jul 24, 2018	10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium S...	CGMP deviations: Product was released while a hood certification discrepancy was being investigated.	Class II	PharMEDium Services, LLC
Jul 13, 2018	Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tab...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Ta...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Ta...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only M...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only M...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tabl...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 13, 2018	Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tabl...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Prinston Pharmaceutical Inc
Jul 12, 2018	Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distr...	Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.	Class II	Sun Pharmaceutical Industries, Inc.
Jul 11, 2018	Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10...	Failed Stability Specifications: lot out of specification for elevated water vapor.	Class III	Renaissance Lakewood, LLC
Jul 11, 2018	Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20...	Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu...	Class III	Renaissance Lakewood, LLC
Jul 11, 2018	Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10...	Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.	Class III	Renaissance Lakewood, LLC
Jul 10, 2018	Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dos...	Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or e...	Class III	Valeant Pharmaceuticals North America LLC
Jul 5, 2018	Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection,...	Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.	Class II	Sanofi-Aventis U.S. LLC
Jul 3, 2018	Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a ...	Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, ...	Class II	Sun Pharmaceutical Industries, Inc.
Jul 2, 2018	Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Do...	Presence of Particulate Matter: identified as glass and silicone material	Class I	AuroMedics Pharma LLC
Jun 28, 2018	Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufac...	Subpotent Drug and Failed Content Uniformity.	Class II	LUPIN SOMERSET
Jun 15, 2018	Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra...	Subpotency: lower than expected potency result was obtained at the 18 month stability time point.	Class III	Validus Pharmaceuticals, Inc.
Jun 15, 2018	Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri...	Subpotency: lower than expected potency result was obtained at the 18 month stability time point.	Class III	Validus Pharmaceuticals, Inc.
Jun 13, 2018	Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Lax...	Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ...	Class III	LUPIN SOMERSET
Jun 12, 2018	Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ...	Failed Impurities/Degradation Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jun 12, 2018	Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ...	Failed Impurities/Degradation Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jun 12, 2018	Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 551...	Failed Impurities/Degradation Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jun 5, 2018	HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in...	Superpotent and Subpotent	Class II	PharMEDium Services, LLC
May 30, 2018	Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr....	Presence of Foreign Substance: A product complaint was received for a defective tablet with an em...	Class II	Dr. Reddy's Laboratories, Inc.
May 24, 2018	Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun...	Labeling: Missing Label	Class III	LUPIN SOMERSET
May 24, 2018	Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians...	Contraceptive Tablets Out of Sequence.	Class I	Allergan, PLC.
May 16, 2018	Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches...	Microbial contamination of NonSterile Product; FDA analysis returned out of specification results...	Class II	Inopak Ltd
May 1, 2018	Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intr...	Presence of Particulate Matter: confirmed customer report for presence of visible particulate mat...	Class I	AuroMedics Pharma LLC
May 1, 2018	Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular...	Presence of Particulate Matter: confirmed customer report of the presence of visible particulate ...	Class I	AuroMedics Pharma LLC
Apr 27, 2018	Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. ...	Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have be...	Class II	Sanofi-Aventis U.S. LLC
Apr 26, 2018	Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473...	Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to...	Class III	Sun Pharmaceutical Industries, Inc.
Apr 23, 2018	Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottl...	Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was foun...	Class II	Dr. Reddy's Laboratories, Inc.
Apr 19, 2018	Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-co...	Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimeth...	Class II	Sun Pharmaceutical Industries, Inc.
Mar 27, 2018	Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/m...	Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee...	Class II	AuroMedics Pharma LLC
Mar 27, 2018	Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administratio...	Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee...	Class II	AuroMedics Pharma LLC
Mar 27, 2018	Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 m...	Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee...	Class II	AuroMedics Pharma LLC
Mar 27, 2018	Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL...	Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee...	Class II	AuroMedics Pharma LLC
Mar 27, 2018	Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)...	Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee...	Class II	AuroMedics Pharma LLC

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.