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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 31, 2013 Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fres... Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial... Class II Fresenius Kabi USA, LLC
Aug 1, 2013 Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Via... Presence of particulate matter: characterized as thin colorless flakes that are visually and chem... Class II Nexus Pharmaceuticals Inc
Jul 1, 2013 Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose ... Presence of particulate matter: characterized as thin colorless flakes that are visually and che... Class II Fresenius Kabi USA, 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.