PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: November 24, 2021 Initiated: October 1, 2021 #D-0253-2022

Product Description

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.

Reason for Recall

Chemical Contamination: presence of benzene

Details

Units Affected
2,841,012 cans
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Location
Whippany, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 2,841,012 cans.
Why was this product recalled?
Chemical Contamination: presence of benzene
Which agency issued this recall?
This recall was issued by the FDA Drug on November 24, 2021. Severity: Critical. Recall number: D-0253-2022.