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
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
- Drug class
- Sunscreen & Personal Care
Timeline
| 1 Oct 2021 | Recall initiated by company | |
| 18 Nov 2021 | Classified by FDA | +48 days |
| 24 Nov 2021 | Published 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.
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.
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Other Tolnaftate recalls
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| Drug | CLASS I | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal recalled by BlistexBlistex | Blistex | Benzene | Nationwide |
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| Drug | CLASS II | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray recalledLotrimin Daily Prevention Deo | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS I | Tinactin (Tolnaftate 1%) Deodorant Powder Spray recalledTinactin | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray recalledLotrimin Daily Prevention Deo | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |