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Browse Drug Recalls

2 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2 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 2 FDA drug recalls.

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DateProductReasonClassFirm
Aug 19, 2021 Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Mark... Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/2... Class II Rhodes Pharmaceuticals, L.P.
Apr 17, 2018 Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-... Failed Dissolution Specification: Low dissolution outside of specifications Class III Rhodes Pharmaceuticals, L.P.

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.