Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Naftifine Hydrochloride Gel Recalled by Tolmar, Inc. Due to Failed Impurities/ degradation specifications: Out-of-Specification test results obtained...
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 Tolmar, Inc. directly.
Affected Products
Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c) Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Quantity: 1271 tubes
Why Was This Recalled?
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Where Was This Sold?
This product was distributed to 1 state: KY
About Tolmar, Inc.
Tolmar, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report