CLASS I Drug recall · Reported 24 Nov 2021 · FDA Enforcement Report
Tinactin (Tolnaftate 1%) Powder Spray recalled by Bayer Healthcare
Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Powder Spray, distributed nationwide in the US. The recall was initiated on 1 Oct 2021 and the FDA has classified it as Class I.
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-0253-2022
- FDA event ID
- 88677
- Recalling firm
- Bayer Healthcare Pharmaceuticals, Whippany, NJ
- Classification
- Class I
- 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 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
Chemical Contamination: presence of benzene
Product as listed by the FDA
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Where it was distributed
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Questions about this recall
Why was it recalled?
Chemical Contamination: presence of benzene
Which lots are affected?
Lot # (a)CV015YS, EXP 9/30/2021 (b) TN008CT, TN007TJ, EXP 3/31/2023
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 88677More recalls from Bayer Healthcare Pharmaceuticals
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Vitrakvi (larotractenib) oral solution, 20mg/mL recalledVitrakvi | Bayer Healthcare Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS I | Lotrimin AF, (Miconazole nitrate 2%), Powder Spray recalled | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Tinactin (Tolnaftate 1%) Jock Itch Powder Spray Net WT133g recalled | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Tinactin (Tolnaftate 1%) Powder Spray recalled by Bayer Healthcare | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
| Drug | CLASS II | Lotrimin AF (Miconazole nitrate 2%) Liquid Spray recalled | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |
Other Tinactin (tolnaftate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tinactin (Tolnaftate 1%) Powder Spray recalled by Bayer Healthcare | Bayer Healthcare Pharmaceuticals | Benzene | Nationwide |