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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

2,193 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,193 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 2,193 FDA drug recalls in NJ.

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DateProductReasonClassFirm
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
Mar 27, 2018 Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... 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, 750 mg Levofloxacin (5 mg/mL) in 150 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 19, 2018 Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... Class III Glenmark Pharmaceuticals Inc., USA
Mar 15, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare Pharmaceuticals, Inc.
Mar 8, 2018 E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Ma... Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - met... Class II Bracco Diagnostics Inc.
Mar 8, 2018 Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... Class III Dr. Reddy's Laboratories, Inc.
Mar 5, 2018 Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... Failed Impurities/Degradation Specifications Class III Novel Laboratories, Inc.
Mar 5, 2018 Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johns... Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morph... Class II Johnson Matthey 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.