Recall archive / FDA drug enforcement
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Produc... — FDA record D-0245-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 1, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
- Reason
- cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
- Classification
- Class II
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Quantity
- 2,841,012 cans
- Agency-reported status
- Terminated
- Source record identifier
- D-0245-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # (a) CV015YT, EXP 10/31/2021; CV01AE7, EXP 2/28/2022; CV01CY2, EXP 4/30/2022'; CV01E6P, EXP 8/31/2022; TN00085, TN001EK, EXP 10/31/2022; TN001ZV, TN00274, EXP 12/31/2022; TN003CU, EXP 1/31/2023; TN003CV, EXP 3/31/2023; TN0047H, EXP 4/30/2023; TN0047R, EXP 5/31/2023; (b)TN0067B, EXP 9/30/2022; TN006AT, EXP 12/31/2022; TN006TA, EXP 2/28/2023; (c) CV01E6PV, CV01E6PD, CV01E6PC, CV01E6PBV, CV01E6PAV, EXP 8/31/2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 24, 2021
- Recall initiation date
- Oct 1, 2021
- Center classification date
- Nov 18, 2021
- Termination date
- Jun 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.