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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 26, 2023 Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, M... Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution wi... Class III VistaPharm LLC
Oct 18, 2023 Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottle... Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. Class I VistaPharm LLC
Oct 17, 2023 Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz... Failed Excipient Specifications: high content of ethylene glycol (EG) Class III VistaPharm LLC
Aug 30, 2023 Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL ... Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results Class II VistaPharm 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.