Medications & Supplements/Prescription Drugs

Naftifine Hydrochloride Gel Recalled for Failed Impurity Specifications

Agency Publication Date: August 1, 2022

Summary

Tolmar, Inc. is recalling 1,271 tubes of Naftifine Hydrochloride Gel, USP 1%, distributed by Amneal Pharmaceuticals LLC. This prescription antifungal medication is being recalled because laboratory testing found unspecified impurities that exceeded the product's quality specifications. The recall affects 40g, 60g, and 90g tubes distributed in cartons to a consignee in Kentucky.

Risk

The presence of unspecified impurities may affect the safety or effectiveness of the medication. No incidents or injuries have been reported in connection with this recall.

What You Should Do

The recalled product is Naftifine Hydrochloride Gel, USP 1%, sold in 40g, 60g, and 90g tubes under the Amneal Pharmaceuticals LLC brand. Check your medication packaging for NDC codes 0115-1510-48, 0115-1510-63, or 0115-1510-58 and lot numbers 12070A, 11801A, 12386A, 11800A, or 11940A with expiration dates ranging from September 2022 to August 2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, Tolmar, Inc., for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Naftifine Hydrochloride Gel, USP 1% (90g tube)

Variants: 90g tube, Gel

Lot Numbers:

12070A (Exp 5/2023)

11801A (Exp 9/2022)

NDC:

0115-1510-48

Rx only; Manufactured by Tolmar, Inc.; Distributed by Amneal Pharmaceuticals LLC.

Product: Naftifine Hydrochloride Gel, USP 1% (40g tube)

Variants: 40g tube, Gel

Lot Numbers:

12386A (Exp 8/2023)

11800A (Exp 9/2022)

NDC:

0115-1510-63

Rx only; Manufactured by Tolmar, Inc.; Distributed by Amneal Pharmaceuticals LLC.

Product: Naftifine Hydrochloride Gel, USP 1% (60g tube)

Variants: 60g tube, Gel

Lot Numbers:

11940A (Exp 12/2022)

NDC:

0115-1510-58

Rx only; Manufactured by Tolmar, Inc.; Distributed by Amneal Pharmaceuticals LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90580

Status: Resolved

Manufacturer: Tolmar, Inc.

Sold By: Amneal Pharmaceuticals LLC; Retail Pharmacies

Manufactured In: United States

Units Affected: 1271 tubes

Distributed To: Kentucky

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is Naftifine Hydrochloride Gel, USP 1%, sold in 40g, 60g, and 90g tubes under the Amneal Pharmaceuticals LLC brand. Check your medication packaging for NDC codes 0115-1510-48, 0115-1510-63, or 0115-1510-58 and lot numbers 12070A, 11801A, 12386A, 11800A, or 11940A with expiration dates ranging from September 2022 to August 2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, Tolmar, Inc., for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Naftifine Hydrochloride Gel, USP 1% (90g tube)

Variants: 90g tube, Gel

Lot Numbers:

12070A (Exp 5/2023)

11801A (Exp 9/2022)

NDC:

0115-1510-48

Rx only; Manufactured by Tolmar, Inc.; Distributed by Amneal Pharmaceuticals LLC.

Product: Naftifine Hydrochloride Gel, USP 1% (40g tube)

Variants: 40g tube, Gel

Lot Numbers:

12386A (Exp 8/2023)

11800A (Exp 9/2022)

NDC:

0115-1510-63

Rx only; Manufactured by Tolmar, Inc.; Distributed by Amneal Pharmaceuticals LLC.

Product: Naftifine Hydrochloride Gel, USP 1% (60g tube)

Variants: 60g tube, Gel

Lot Numbers:

11940A (Exp 12/2022)

NDC:

0115-1510-58

Rx only; Manufactured by Tolmar, Inc.; Distributed by Amneal Pharmaceuticals LLC.