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Browse Drug Recalls

1,020 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,020 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 1,020 FDA drug recalls.

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DateProductReasonClassFirm
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated
Aug 29, 2012 BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactu... Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine v... Class I Bristol-myers Squibb Company
Aug 17, 2012 Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by... Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide... Class III Axcentria Pharmaceuticals LLC
Aug 14, 2012 Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phen... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 14, 2012 Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 7, 2012 Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactu... Cross Contamination w/Other Products: During stability testing chromatographic review revealed ex... Class II Mylan Pharmaceuticals Inc.
Jul 25, 2012 Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 25, 2012 Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 25, 2012 Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 25, 2012 Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... Subpotent; 9-month stability interval Class II Lloyd Inc. of Iowa
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bott... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottl... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
Jul 19, 2012 Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottl... Defective Container: A number of Synthroid bottles have a localized thin wall defect on the botto... Class II Abbott Laboratories
Jun 28, 2012 Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceutic... Impurities/Degradation Products: Out of specification results for Related Compound during routine... Class III Mylan Pharmaceuticals Inc.
May 30, 2012 Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL,... Impurities/Degradation Products: exceeded specification at 3 month stability testing Class II VistaPharm, Inc.
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.
Mar 29, 2012 buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets... Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... Class III McKesson Packaging Services
Mar 29, 2012 buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets... Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at th... Class III McKesson Packaging Services
Jul 6, 2011 Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottl... Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulos... Class II Bausch & Lomb, 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.