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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
Jan 19, 2018 Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... Discoloration: Product is supposed to be a white to off white homogenous cream and may have inter... Class III G & W Laboratories, Inc.
Jun 2, 2017 G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 071... Failed impurities/degradation specifications: This product is being recalled due to out of specif... Class III G & W Laboratories, Inc.
Mar 20, 2017 Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. Class III G & W Laboratories, 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.
Feb 7, 2017 Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in b... Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and ... Class II G & W Laboratories, 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.