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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Oct 7, 2013 Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules ... Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 m... Class II Amedra Pharmaceuticals LLC
Dec 4, 2012 Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... Class II Amedra Pharmaceuticals LLC
Dec 4, 2012 Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... Class II Amedra Pharmaceuticals LLC
Dec 4, 2012 Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on... Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut... Class II Amedra Pharmaceuticals LLC

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.