Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fougera Ketoconazole Cream 2% Recalled by Fougera Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fougera Pharmaceuticals Inc. directly.
Affected Products
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
Quantity: 60,210 units
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fougera Pharmaceuticals Inc.
Fougera Pharmaceuticals Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report