Naftifine Hydrochloride Gel recalled for failed impurity specifications
Tolmar Inc. recalls Naftifine Hydrochloride Gel 1% due to out-of-specification impurity test results. The recalled tubes may contain unidentified impurities that exceed acceptable limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with confirmed quality defects—out-of-specification impurity testing. While no reported illnesses or injuries exist, the unspecified impurities in a pharmaceutical product represent a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Tolmar Inc. is recalling Naftifine Hydrochloride Gel, USP 1%, a prescription topical antifungal medication, due to failed impurity and degradation specifications. Manufacturing testing revealed out-of-specification results for unspecified impurities, indicating that some tubes may contain contaminants or degradation products at levels exceeding acceptable standards.
The recall affects 1,271 tubes across three package sizes: 90g (NDC 0115-1510-48), 40g (NDC 0115-1510-63), and 60g (NDC 0115-1510-58). The affected product was distributed to one consignee in Kentucky.
Consumers who have this medication should stop using it and contact their healthcare provider or pharmacy for guidance. The unspecified impurities present a potential safety concern for this pharmaceutical product.
The recalled product
- Product
- 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 Pharmace
- Manufacturer
- Tolmar, Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- unspecified-impurity
- degradation-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #: a) 12070A
- Exp 5/2023
- 11801A
- Exp 9/2022
- b) 12386A
- Exp 8/2023
- 11800A
- c) 11940A
- Exp 12/2022
Distribution
Distributed in 1 state:
- KY
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