RecallRadar

FDA Drug recall D-0242-2022

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of…

On 2021-11-24 the FDA classified a Class II recall of Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of… by Bayer Healthcare Pharmaceuticals, citing cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0242-2022
ClassificationClass II
Statusterminated
Initiated2021-10-01
Published2021-11-24
Last updated2026-09-13 11:52 UTC
CompanyBayer Healthcare Pharmaceuticals
DistributionUS

Product

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981

Reason

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Identifiers

upc311017410004
ndc11523-4162-1
ndc11017-410-00
code_infoLot # (a) TN004BW, EXP 7/31/2022, (b) TN00678, EXP 8/31/2022; TN00679, EXP 9/30/2022;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0242-2022%22

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