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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
Jul 21, 2022 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... Failed Dissolution Specifications: below specification limits for dissolution. Class II Teva Pharmaceuticals USA Inc
Oct 28, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ... Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ... Class II Teva Pharmaceuticals USA
Mar 16, 2016 Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL... Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-sp... Class III Actavis Pharma 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.