CLASS II Drug recall · Reported 24 Nov 2021 · FDA Enforcement Report

Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray recalled

Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, distributed nationwide in the US. The recall was initiated on 1 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # (a)TN0023C, EXP 1/31/2022; TN003C7, EXP 4/30/2022; TN00570, EXP 7/31/2022; TN0056Z, TN005KJ, EXP 8/31/2022; (b)TN0023C, EXP 01/31/2022; TN003C7, EXP 04/30/2022; TN0023DV, TN0023DAV, TN0023DBV, TN0023DC, EXP 02/28/2022; TN005KJ, TN005KJA, TN005KJB, EXP 08/31/2022;
NDC11523-0010
UPC041100587206, 041100589613
Quantity recalled579,456 cans

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0240-2022
FDA event ID
88677
Recalling firm
Bayer Healthcare Pharmaceuticals, Whippany, NJ
Manufacturer
Bayer HealthCare LLC.
Classification
Class II
Status
Terminated
Recall initiated
1 Oct 2021
FDA classified
18 Nov 2021
Reported
24 Nov 2021
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Benzene

Timeline

1 Oct 2021Recall initiated by company
18 Nov 2021Classified by FDA+48 days
24 Nov 2021Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,

Where it was distributed

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Nationwide Puerto Rico

Questions about this recall

Is Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray recalled?

Yes. Bayer Healthcare Pharmaceuticals recalled Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray on 1 Oct 2021. The recall is Class II and its status is Terminated. Recall number D-0240-2022.

Why was it recalled?

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

Which lots are affected?

Lot # (a)TN0023C, EXP 1/31/2022; TN003C7, EXP 4/30/2022; TN00570, EXP 7/31/2022; TN0056Z, TN005KJ, EXP 8/31/2022; (b)TN0023C, EXP 01/31/2022; TN003C7, EXP 04/30/2022; TN0023DV, TN0023DAV, TN0023DBV, TN0023DC, EXP 02/28/2022; TN005KJ, TN005KJA, TN005KJB, EXP 08/31/2022;

Where was it sold?

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Bayer Healthcare Pharmaceuticals

All 30

Other Tolnaftate recalls

All 9