Tinactin Liquid Spray (Bayer) - Manufacturing Deviation (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Healthcar
Brand
Bayer Healthcare Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot # (a)TN0060U, TN0060V, TN0060W, EXP 7/31/2022, TN0060X, TN0060Y, TN0060Z, TN006CJ, TN006CK, TN006CM, TN00610, EXP 9/30/2022, TN006YW, EXP 10/31/2022, TN006MY, TN006YX, TN006YY, EXP 12/31/2022, TN007EN, TN007EP, TN007ER, EXP 2/28/2023, (b)CV016TH, CV016TJ, CV017D8, CV017D7, EXP 10/31/2021, CV017XS, EXP 11/30/2021, CV01980, CV019DS, EXP 12/31/2021, CV01A72, CV01A73, CV01AE6, EXP 1/31/2022, CV01AUA, CV01B1E, EXP 2/28/2022, CV01BNE, EXP 3/31/2022, CV01BVU, EXP 3/31/2022, CV01CT6, CV01CY1, EXP 4/30/2022, CV01D2G, EXP 5/31/2022, CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022, CV01E2W, CV01E2X, EXP 7/31/2022, CV01E2U, EXP 7/31/2022, CV01E2V, EXP 8/31/2022, TN001V6, EXP 11/30/2022, TN00243, EXP 12/31/2022, TN0024B, TN0024C, TN0024D, TN0024E, TN003C6, EXP 1/31/2023, TN00408, TN00409, TN0047J, TN0047K, TN0040A, EXP 4/30/2022, (c) CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022
Products Sold
Lot # (a)TN0060U, TN0060V, TN0060W, EXP 7/31/2022; TN0060X, TN0060Y, TN0060Z, TN006CJ, TN006CK, TN006CM, TN00610, EXP 9/30/2022; TN006YW, EXP 10/31/2022; TN006MY, TN006YX, TN006YY, EXP 12/31/2022; TN007EN, TN007EP, TN007ER, EXP 2/28/2023; (b)CV016TH, CV016TJ, CV017D8, CV017D7, EXP 10/31/2021; CV017XS, EXP 11/30/2021; CV01980, CV019DS, EXP 12/31/2021; CV01A72, CV01A73, CV01AE6, EXP 1/31/2022; CV01AUA, CV01B1E, EXP 2/28/2022; CV01BNE, EXP 3/31/2022; CV01BVU, EXP 3/31/2022; CV01CT6, CV01CY1, EXP 4/30/2022; CV01D2G, EXP 5/31/2022; CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022; CV01E2W, CV01E2X, EXP 7/31/2022; CV01E2U, EXP 7/31/2022; CV01E2V, EXP 8/31/2022; TN001V6, EXP 11/30/2022; TN00243, EXP 12/31/2022; TN0024B, TN0024C, TN0024D, TN0024E, TN003C6, EXP 1/31/2023; TN00408, TN00409, TN0047J, TN0047K, TN0040A, EXP 4/30/2022, (c) CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022
Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 200 due to cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026