The Recall Desk
HighFDA (Drugs)·D-0243-2022·Announced 2021-11-24

Tinactin Tolnaftate Spray Recalled for Potential Benzene Contamination

Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) liquid spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for potential contamination by benzene, a known human carcinogen. Although no illnesses or injuries are reported, benzene poses a significant health risk even at low levels of exposure, which justifies a High severity rating.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) liquid spray (150g/5.3 oz cans) due to potential benzene contamination. The recall is prompted by cGMP deviations—the product was manufactured at the same facility where other lots were found to be contaminated with benzene.

The affected product includes cans manufactured in Finland and Ireland with various lot numbers and expiration dates ranging from July 2021 through February 2023. The product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through a variety of retail channels.

Consumers who have purchased this product should stop using it. Consumers with questions about the recall may contact Bayer Healthcare's consumer care line at the phone number on the product packaging.

The recalled product

Product
TINACTIN (TOLNAFTATE)
Brand
TINACTIN
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical OTC Drug
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 (20)

  • Lot # (a)TN0060U
  • TN0060V
  • TN0060W
  • EXP 7/31/2022
  • TN0060X
  • TN0060Y
  • TN0060Z
  • TN006CJ
  • TN006CK
  • TN006CM
  • TN00610
  • EXP 9/30/2022
  • TN006YW
  • EXP 10/31/2022
  • TN006MY
  • TN006YX
  • TN006YY
  • EXP 12/31/2022
  • TN007EN
  • TN007EP

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.

See all →

Same hazard · benzene contamination

See all →