Browse Drug Recalls

1,032 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,032 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 1,032 FDA drug recalls.

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DateProductReasonClassFirm
Nov 21, 2012 Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx on... Subpotent; 22 month stability timepoint Class III Hill Dermaceuticals, Inc.
Nov 21, 2012 Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx o... Subpotent; 12 month stability timepoint Class III Hill Dermaceuticals, Inc.
Nov 15, 2012 Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles... Subpotent; 15 month stability (by mfr) Class II Physicians Total Care, Inc.
Nov 6, 2012 VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vi... Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity... Class II Alkermes, Inc.
Oct 29, 2012 Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by ... Subpotent; 15 month stability Class II Alara Pharmaceutical Co
Oct 24, 2012 Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation A... Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... Class III GlaxoSmithKline, LLC.
Oct 24, 2012 Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 m... Product Lacks Stability: These lots are being recalled due to the failure to meet the particle si... Class III GlaxoSmithKline, LLC.
Oct 23, 2012 ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxida... Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stabl... Class III Estee Lauder Inc
Oct 10, 2012 QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packa... Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months ... Class II American Health Packaging
Oct 3, 2012 Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., M... Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (ex... Class II Paddock Laboratories, LLC
Sep 27, 2012 Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd B... Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 mon... Class II Dr. Reddy's Laboratories, Inc.
Sep 12, 2012 Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, R... Impurities/Degradation Products: An out of specification result for a known impurity of the produ... Class III Sandoz Incorporated
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.