The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0242-2022·Announced 2021-11-24

Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination

Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to potential benzene contamination. The product was manufactured at a facility where other lots tested positive for benzene.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a drug product. Although no illnesses are reported in the source text, the hazard—benzene contamination—is a serious carcinogen. The facility-wide cGMP deviation with confirmed contamination in other lots justifies a Severe classification.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray, a topical antifungal product sold in 133g (4.6 oz) cans. The recall affects approximately 738,432 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico through various retail channels.

The recall was initiated because the product was manufactured at a facility where other lots were found to be contaminated with benzene, a known carcinogen. Affected lots include TN004BW (expiration 7/31/2022), TN00678 (expiration 8/31/2022), and TN00679 (expiration 9/30/2022).

Consumers who have purchased this product should stop using it. Those who have used the product and have health concerns should consult a healthcare provider. For additional information, consumers may contact Bayer Healthcare or check the FDA website for updates on this recall.

The recalled product

Product
TINACTIN (TOLNAFTATE)
Brand
TINACTIN
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical Antifungal
Hazard
Affected units
738,432

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 (6)

  • Lot # (a) TN004BW
  • EXP 7/31/2022
  • (b) TN00678
  • EXP 8/31/2022
  • TN00679
  • EXP 9/30/2022

UPCs (2)

  • 0311017410004
  • 311017410004

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 →

Similar recalls