The Recall Desk
SevereFDA (Drugs)·D-0251-2022·Announced 2021-11-24

Tinactin Tolnaftate Liquid Spray Recalled for Benzene Contamination

Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) liquid spray due to the presence of benzene chemical contamination. The product was distributed nationwide through retail channels.

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: The FDA classified this as a Class I recall, which per the rubric requires a minimum severity score of 4. Benzene is a known carcinogen and chemical contaminant that presents serious potential health risk, meeting the criteria for a Severe classification.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Liquid Spray in 150g (5.3 oz) cans due to the presence of benzene, a chemical contaminant. The recalled product includes cans manufactured in Finland (Lot #TN006MX, EXP 10/31/2022; TN00BKV, TN008D1, TN008D2, EXP 3/31/2023) and Ireland (Lot #CV0180B, EXP 12/31/2021; TN003C5, EXP 1/31/2023). The UPC is 3 11017 41005 9 and the NDC is 11523-0165-3.

The product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels. A total of 4,990,860 cans are affected by this recall.

Consumers who have purchased this product should stop using it and contact Bayer Healthcare for further instructions. Exposure to benzene can present serious health risks. Anyone with questions about this recall should contact the company through the FDA's recall page.

The recalled product

Product
TINACTIN (TOLNAFTATE)
Brand
TINACTIN
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical OTC
Hazard
Affected units
4,990,860

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 (10)

  • Lot # (a)TN006MX
  • EXP 10/31/2022
  • TN00BKV
  • TN008D1
  • TN008D2
  • EXP 3/31/2023
  • (b) CV0180B
  • EXP12/31/2021
  • TN003C5
  • EXP 1/31/2023

UPCs (2)

  • 0311017410059
  • 311017410059

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 recalled by Bayer Healthcare Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Related recalls

Same brand · TINACTIN

Same manufacturer · Bayer Healthcare Pharmaceuticals Inc.

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Same hazard · benzene

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