US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 1, 2021 (5 years ago)

Lotrimin Af

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

Why it was recalled

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

What was recalled

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.

Recalling firm
Bayer Healthcare Pharmaceuticals Inc.
NDC code
11523-0010-1
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0239-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Tolnaftate recalls

See all
Class II · Moderate risk Completed

Blis-To-Sol Liquid

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

Ecometics, Inc. D-1096-2023
Class I · High risk Terminated

Odor-Eaters Spray Powder

Reason Chemical contamination: Presence of benzene

Blistex Inc NDC 10157-4645-1 D-0159-2024
Class II · Moderate risk Terminated

Lotrimin Af

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

Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0010-2 D-0254-2022
Class I · High risk Terminated

Tinactin

Reason Chemical Contamination: presence of benzene

Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0777-2 D-0253-2022