Tinactin — Class II drug recall D-0243-2022
Terminated recall by Bayer Healthcare Pharmaceuticals Inc., reported 2021-11-24, distributed nationwide. cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene
| Recall number | D-0243-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| 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, cgmp |
| UPC / GTIN / UDI-DI | 00311017410059 |
| NDC | 11523-0165, 11523-0165-03 |
| Lot numbers | CV016TJ, CV017D7, CV017D8, CV017XS, CV01980, CV019DS, CV01A72, CV01A73, CV01AE6, CV01AUA, CV01B1E, CV01BNE, CV01BVU, CV01CT6, CV01CY1, CV01D2G, CV01DRX, CV01DRY, CV01E2T, CV01E2U, CV01E2V, CV01E2W, CV01E2X, TN001V6, TN00243, TN0024B, TN0024C, TN0024D, TN0024E, TN003C6, TN00408, TN00409, TN0040A, TN0047J, TN0047K, TN0060V, TN0060W, TN0060X, TN0060Y, TN0060Z and 11 more |
| Expiration dates | 2021-10-31, 2021-11-30, 2021-12-31, 2022-01-31, 2022-02-28, 2022-03-31, 2022-04-30, 2022-05-31, 2022-06-30, 2022-07-31, 2022-08-31, 2022-09-30, 2022-10-31, 2022-11-30, 2022-12-31, 2023-01-31, 2023-02-28 |
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.
Reason for recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with 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-0243-2022. 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.