Naftifine Hydrochloride Gel — Class II drug recall D-1300-2022
Terminated recall by Tolmar, Inc., reported 2022-08-10, distributed in KY. Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impu
| Recall number | D-1300-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tolmar, Inc., Fort Collins, CO, United States |
| Recall initiated | 2022-07-11 |
| Classified | 2022-08-01 |
| Reported by FDA | 2022-08-10 |
| Terminated | 2023-06-22 |
| Distributed | KY |
| Quantity | 1,271 tubes |
| Reason classes | specification failure |
| NDC | 00115-1510-48, 00115-1510-58, 00115-1510-63 |
| Expiration dates | 2022-09, 2022-12, 2023-05, 2023-08 |
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 Pharmaceuticals LLC, Bridgewater, NJ 08807
Reason for recall
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1300-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.