Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
KETOCONAZOLE CREAM Recalled by Fougera Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Quantity: 31,122 tubes
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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