Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Tolnaftate recalled?

Not under an active recall. Tolnaftate was recalled 15 times in the past — all now closed. Most recent: Feb 1, 2024.

Most common reason: Chemical / undeclared (14 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Tolnaftate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Tolnaftate recalls on record

none so far in 2026; 15 on record, newest first
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
Class II · Moderate risk

Lotrimin Af

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

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

Lotrimin AF

Chemical Contamination: presence of benzene

Terminated Chemical / undeclared Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0010-2 D-0249-2022
Class II · Moderate risk

Tinactin (Tolnaftate 1%)

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

Terminated Chemical / undeclared Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0777-2 D-0245-2022
Class II · Moderate risk

Tinactin (Tolnaftate 1%)

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

Terminated Chemical / undeclared Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0072-5 D-0244-2022
Class II · Moderate risk

Tinactin (Tolnaftate 1%)

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

Terminated Chemical / undeclared Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0165-3 D-0243-2022
Class II · Moderate risk

Tinactin (Tolnaftate 1%)

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

Terminated Chemical / undeclared Bayer Healthcare Pharmaceuticals Inc. NDC 11523-4162-1 D-0242-2022
Class II · Moderate risk

Lotrimin Af

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

Terminated Chemical / undeclared Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0010-2 D-0240-2022
Class II · Moderate risk

Lotrimin Af

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

Terminated Chemical / undeclared Bayer Healthcare Pharmaceuticals Inc. NDC 11523-0010-1 D-0239-2022