The Recall Desk
SevereFDA (Drugs)·D-0250-2022·Announced 2021-11-24

Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination

Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to the presence of benzene chemical contamination. The recall affects 738,432 cans distributed nationwide and internationally.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I by the agency, which per the rubric criteria requires a minimum score of 4. Benzene is a known toxic chemical, and this is a topical antifungal drug product distributed to hundreds of thousands of consumers, meeting the threshold for a Severe classification.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray, a topical antifungal drug product sold over-the-counter. The recall was initiated due to the presence of benzene, a chemical contaminant, in the product.

The affected product is Tinactin Deodorant Powder Spray with a net weight of 133g (4.6 oz) in aerosol cans. The recalled lots are: Lot # TN0067A with expiration date 2/28/2023 and Lot # TN008CU with expiration date 4/30/2023. The product is identified by UPC 3 11017 41000 4 and NDC 11523-4162-1.

Approximately 738,432 cans have been distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through a variety of retail channels. The product was manufactured in Finland.

Consumers who have purchased this product should stop using it immediately. If you have questions about this recall or believe you have been affected, contact the manufacturer or consult a healthcare professional.

The recalled product

Product
TINACTIN (TOLNAFTATE)
Brand
TINACTIN
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Hazard
  • benzene-contamination
  • chemical-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot # TN0067A
  • EXP 2/28/2023
  • TN008CU
  • EXP 4/30/2023

UPCs (2)

  • 0311017410004
  • 311017410004

Distribution

Distributed nationwide across the United States.