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Browse Drug Recalls

112 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 112 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 112 FDA drug recalls.

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DateProductReasonClassFirm
Jul 1, 2014 Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Jan 31, 2014 HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... Class II American Health Packaging
Aug 21, 2013 buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2... Class III Actavis South Atlantic LLC
Aug 2, 2013 Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only,... Subpotent Class II American Health Packaging
Jul 31, 2013 BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count table... Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above appro... Class III Actavis Inc
May 21, 2013 Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carto... Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which cou... Class II American Health Packaging
Mar 22, 2013 buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablet... Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour ... Class III Actavis South Atlantic LLC
Feb 4, 2013 buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carto... Failed Stability Specifications; out of specification results at the 9 month stability time point... Class III American Health Packaging
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
Jul 25, 2012 Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, R... Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly... Class III American Health Packaging
Jul 23, 2012 Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... Class II American Health Packaging

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.