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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Mar 15, 2021 Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Feb 28, 2017 Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicat... CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. Class III G & W Laboratories, Inc.
May 15, 2013 Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactu... Failed Impurity/Degradation Specification; "Related Compound C" Class II Actavis South Atlantic LLC
Aug 14, 2012 Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic LLC
Aug 14, 2012 Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phen... Impurities/Degradation Products: Recalled lots do not meet room temperature stability specificati... Class III Actavis Mid Atlantic 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.