Fougera Pharmaceuticals Inc.

Complete recall history across all FDA and CPSC categories — 7 total recalls

Fougera Pharmaceuticals Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (7)

FDA drug safety enforcement actions by Fougera Pharmaceuticals Inc.

Date Product Reason Class
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 cont... Class II
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% reca... Class II
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 reca... Class III
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 reca... Class III
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 fl... Class III
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 ... Class III
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 su... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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