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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
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
May 15, 2013 Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactu... Failed Impurity/Degradation Specification; "Related Compound C" Class II Actavis South Atlantic LLC
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
Jan 4, 2013 buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bot... Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. Class III Actavis Pharmaceuticals

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.