Tinactin — Class I drug recall D-0251-2022
Terminated recall by Bayer Healthcare Pharmaceuticals Inc., reported 2021-11-24, distributed nationwide. Chemical Contamination: presence of benzene
| Recall number | D-0251-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, United States |
| Recall initiated | 2021-10-01 |
| Classified | 2021-11-18 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2023-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 4,990,860 cans |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 00311017410059 |
| NDC | 11523-0165, 11523-0165-03 |
| Lot numbers | CV0180B, TN003C5, TN008D1, TN008D2, TN00BKV |
| Expiration dates | 2021-12-31, 2022-10-31, 2023-01-31, 2023-03-31 |
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.
Reason for recall
Chemical Contamination: presence of benzene
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0251-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.