Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Oct 1, 2021 (5 years ago)

Lotrimin Af (Tolnaftate)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What was recalled

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2

Affected NDC 11523-0010-02

Compare with the code on your package — it is the most precise check available.

Drug: Tolnaftate

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Lotrimin Daily Prevention Deo
Tolnaftate
NDC 11523-0010
10 mg/g Aerosol, Powder
Topical
Bayer HealthCare LLC. OTC
Recalling firm
Bayer Healthcare Pharmaceuticals Inc.
NDC code
11523-0010-2
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0254-2022 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Tolnaftate recalls

See all
Class II · Moderate risk

Blis-To-Sol Liquid

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Completed cGMP deviation Ecometics, Inc. D-1096-2023

Other recalls by Bayer Healthcare Pharmaceuticals Inc.

All 2021 recalls
Class I · High risk

VITRAKVI (larotractenib)

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Terminated Microbial contamination Bayer Healthcare Pharmaceuticals Inc. NDC 50419-392-01 D-0145-2024