CLASS II Drug recall · Reported 10 Aug 2022 · FDA Enforcement Report
Naftifine Hydrochloride Gel recalled by Tolmar
Tolmar is recalling Naftifine Hydrochloride Gel, USP 1%, distributed in Kentucky. The recall was initiated on 11 Jul 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1300-2022
- FDA event ID
- 90580
- Recalling firm
- Tolmar, Fort Collins, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2022
- FDA classified
- 1 Aug 2022
- Reported
- 10 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Jul 2022 | Recall initiated by company | |
| 1 Aug 2022 | Classified by FDA | +21 days |
| 10 Aug 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
distributed to 1 consignee in KY.
Questions about this recall
Why was it recalled?
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Which lots are affected?
Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022
Where was it sold?
distributed to 1 consignee in KY.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tolmar
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Eligard (leuprolide acetate) for injectable suspension recalledEligard | Tolmar | Potency & Assay | Nationwide |
| Drug | CLASS II | Clindamycin and Benzoyl Peroxide Gel, 1%/5% recalled by TOLMAR | Tolmar | Potency & Assay | Nationwide |
| Drug | CLASS III | Ketoconazole Shampoo recalled by Tolmar | Tolmar | Potency & Assay | Nationwide |