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Browse Drug Recalls

3 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3 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 3 FDA drug recalls.

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DateProductReasonClassFirm
Oct 27, 2023 Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card ... Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet wit... Class III NCS Healthcare of Kentucky Inc
Oct 27, 2023 Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-... Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet wit... Class III NCS Healthcare of Kentucky Inc
Jan 28, 2020 Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUT... Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unk... Class II NCS Healthcare of Kentucky 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.