Unrated Drug recall · FDA · Published July 11, 2022

Tolmar Naftifine Gel Recall: Impurities May Cause Harm

Tolmar recalls Naftifine Hydrochloride Gel 1% due to failed impurities tests. This prescription gel may contain harmful substances. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1300-2022Drug Tolmar ›

Recall notice

Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

Take action

Contact the company

Recalling firmTolmar, Inc.701 Centre Ave · Fort Collins, CO 80526-1843

✎ GovInfoNow plain-language explainer

Tolmar is recalling Naftifine Hydrochloride Gel 1% products because tests found impurities that could be harmful. This prescription medication may pose a risk to users if the impurities cause adverse effects. Read more at govinfonow.com/recall/34431-tolmar-naftifine-gel-recall-impurities-may-cause-harm.

Source Summary by GovInfoNow · govinfonow.com/recall/34431-tolmar-naftifine-gel-recall-impurities-may-cause-harm · Updated September 23, 2026 · FDA enforcement record: FDA #D-1300-2022

Cite this page

“Tolmar Naftifine Gel Recall: Impurities May Cause Harm.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34431-tolmar-naftifine-gel-recall-impurities-may-cause-harm. Based on FDA recall #D-1300-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1300-2022%22&limit=1).

The FDA announced on July 11, 2022, that Tolmar, Inc. is recalling Naftifine Hydrochloride Gel, USP 1% due to failed impurity specifications. The recall affects specific lots distributed to one consignee in Kentucky.

How to tell if you have it

Brand: Tolmar
Product: Naftifine Hydrochloride Gel, USP 1%
NDC 0115-1510-48 (Net Wt. 90g tube)
NDC 0115-1510-63 (Net Wt. 40g tube)
NDC 0115-1510-58 (Net Wt. 60g tube)
Lot #12070A, Exp 5/2023
Lot #11801A, Exp 9/2022
Lot #12386A, Exp 8/2023
Lot #11800A, Exp 9/2022
Lot #11940A, Exp 12/2022

The hazard

The product failed specifications for Unspecified Impurity Relative Retention Time. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Tolmar, Inc. has issued three other recalls since September 23, 2013. Other recent recalls of similar products include Sun Pharmaceutical Diclofenac Gel Recall (January 27, 2026), Sun Pharmaceutical Fexofenadine 180mg Tablets Recall (June 1, 2026), and Novadoz Glycopyrrolate Oral Solution Recall (December 15, 2025).

How to tell if you have this one

Check for the following lot numbers: 12070A (exp 5/2023), 11801A (exp 9/2022), 12386A (exp 8/2023), 11800A (exp 9/2022), and 11940A (exp 12/2022). The product comes in 90g, 40g, or 60g tubes with specific NDC codes.

Brand
Tolmar
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot numbers listed: 12070A, 11801A, 12386A, 11800A, or 11940A on the tube.

Where it went and when

Where it was distributed

Distributed in Kentucky.

FDA distribution: “distributed to 1 consignee in KY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Kentucky.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Jul 11, 2022Firm started the recall
Aug 1, 2022FDA classified it Class II
Aug 10, 2022Published in FDA’s Enforcement Report
Jun 22, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/34431-tolmar-naftifine-gel-recall-impurities-may-cause-harm">Tolmar Naftifine Gel Recall: Impurities May Cause Harm (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1300-2022 (July 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1300-2022 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.