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.

Clear
DateProductReasonClassFirm
Apr 18, 2015 Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100... Failed Impurities/Degradation Specifications Class III Valeant Pharmaceuticals North America LLC
Apr 17, 2015 Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.... Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time po... Class II Valeant Pharmaceuticals North America LLC
Apr 15, 2015 Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppres... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class II Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Ma... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorpha... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain ... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Apr 15, 2015 Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli... Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported f... Class III Sandoz, Inc
Apr 15, 2015 Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pai... Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... Class I Reckitt Benckiser LLC
Mar 25, 2015 GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bot... Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Class II Heritage Pharmaceuticals, Inc.
Mar 12, 2015 Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-0... Failed Tablet/Capsule Specifications: out of specification for thickness. Class II Wockhardt Usa Inc.
Mar 9, 2015 Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, R... Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impac... Class II Navinta LLC
Feb 25, 2015 RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcu... Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu... Class II Heritage Pharmaceuticals, Inc.
Feb 25, 2015 Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by:... Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with qu... Class II Heritage Pharmaceuticals, Inc.
Feb 16, 2015 Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5... Failed Impurities/Degradation Specifications; 12 month stability testing. Class III West-Ward Pharmaceutical Corporation
Feb 12, 2015 Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx... Subpotent Drug Class II Actavis Inc
Feb 12, 2015 Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx... Subpotent Drug Class II Actavis Inc
Feb 10, 2015 Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles,... Failed Dissolution Specifications Class II Actavis Elizabeth LLC
Dec 31, 2014 Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Ad... Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 3... Class II Valeant Pharmaceuticals North America LLC
Dec 23, 2014 Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthca... Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Class II Zydus Pharmaceuticals USA Inc
Dec 15, 2014 Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactu... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Dec 4, 2014 Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: M... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-c... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: M... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Nov 26, 2014 Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured b... Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules. Class II Zydus Pharmaceuticals USA Inc
Nov 10, 2014 Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-releas... Defective container: A customer complaint revealed the presence of a defective seal on the top of... Class III Reckitt Benckiser LLC
Oct 17, 2014 Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for... Failed Tablet/Capsule Specifications: Complaints of empty capsules received. Class II Aurobindo Pharma USA Inc
Oct 9, 2014 GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 50... Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification res... Class II Micro Labs Usa, Inc ...
Oct 2, 2014 Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufacture... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Oct 2, 2014 candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur... Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated ... Class III Sandoz, Inc
Oct 2, 2014 VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co... Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point. Class II West-Ward Pharmaceutical Corp.
Oct 2, 2014 Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, M... Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... Class III Valeant Pharmaceuticals International
Oct 1, 2014 Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manuf... Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344. Class III Zydus Pharmaceuticals USA Inc
Sep 24, 2014 BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured... Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsu... Class III Zydus Pharmaceuticals USA Inc
Sep 22, 2014 LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufact... Failed Content Uniformity Specifications; Dry mix failed blend uniformity. Class II Micro Labs Usa, Inc ...
Sep 18, 2014 E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -c... Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. Class III Bracco Diagnostic Inc
Sep 15, 2014 TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila... Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. Class II Zydus Pharmaceuticals USA Inc
Sep 5, 2014 Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Sep 5, 2014 Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Sep 5, 2014 Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharm... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Sep 5, 2014 Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Ph... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Aug 28, 2014 Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Onl... Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uni... Class II Alvogen, Inc
Aug 25, 2014 Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only... Subpotent Drug Class II Actavis Inc
Aug 25, 2014 Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only... Subpotent Drug Class II Actavis Inc
Aug 19, 2014 Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: ... Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy ... Class III Micro Labs Usa, Inc ...
Aug 5, 2014 ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufacture... Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were notic... Class II Zydus Pharmaceuticals USA Inc
Jul 24, 2014 Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-c... Failed Dissolution Specifications: Dissolution failures found during testing of control samples a... Class II Wockhardt Usa 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.