---
title: "Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g... — FDA record D-1300-2022 | Is It on Recall"
description: "Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time"
url: https://isitonrecall.com/recall/fda-drug-d-1300-2022-naftifine-hydrochloride-gel-usp-1-packaged-in-cartons-with-a-net-wt-90g-tube-ndc-0115-1510-48-b-net/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g... — FDA record D-1300-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
- **Classification**: Class II
- **Recalling firm**: Tolmar, Inc.
- **Quantity**: 1271 tubes
- **Agency-reported status**: Terminated
- **Source record identifier**: D-1300-2022

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1300-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

distributed to 1 consignee in KY.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Kentucky](https://isitonrecall.com/state/kentucky/)

## Dates in the source

- **Report date**: Aug 10, 2022
- **Recall initiation date**: Jul 11, 2022
- **Center classification date**: Aug 1, 2022
- **Termination date**: Jun 22, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1300-2022%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [TOLMAR, Inc. records](https://isitonrecall.com/brand/tolmar-inc/)