Tolnaftate recalls: 9 FDA reports
Recalls involving Tolnaftate. What was wrong with each batch, and how the FDA graded the risk.
9Reports
4Class I
0Ongoing
2023-12-27Most recent
4 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC
D-0159-2024 · Class I · reported 2023-12-27 · Terminated
- Why it was recalled
- Chemical contamination: Presence of benzene
- Product
- Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
- Where it went
- Nationwide with the USA, Canada and Korea
- How much
- 243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total)
Class I
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b
D-0251-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 4,990,860 cans
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4,
D-0242-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 738,432 cans
Class I
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer
D-0249-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 579,456 cans
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer H
D-0239-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- 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.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 77,076 cans
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a)
D-0240-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- 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 went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 579,456 cans
Class I
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whipp
D-0250-2022 · Class I · reported 2021-11-24 · Terminated
- Why it was recalled
- Chemical Contamination: presence of benzene
- Product
- Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 738,432 cans
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 587
D-0254-2022 · Class II · reported 2021-11-24 · Terminated
- 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.
- Product
- 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
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 579,456 units
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b)
D-0243-2022 · Class II · reported 2021-11-24 · Terminated
- Why it was recalled
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Product
- Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
- Where it went
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- How much
- 4,990,860 cans
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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