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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Mar 2, 2017 Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A... Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonid... Class II Fougera Pharmaceuticals Inc.
Aug 28, 2014 FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalm... Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet t... Class II Fougera Pharmaceuticals Inc.
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatol... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jul 3, 2014 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermat... Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet s... Class III Fougera Pharmaceuticals Inc.
Jan 29, 2014 Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E... Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% ra... Class III Fougera Pharmaceuticals Inc.
Nov 18, 2013 KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division o... Failed Impurities/Degradation Specifications: Out-of-Specification degradant results. Class III Fougera Pharmaceuticals Inc.
Jul 18, 2012 Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & C... Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary... Class III Fougera Pharmaceuticals 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.