🔍 RecallPedia

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2

Class I - Dangerous
💊 Drugs Recalled: October 1, 2021 Bayer Healthcare Pharmaceuticals Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bayer Healthcare Pharmaceuticals Inc.
Reason for Recall:
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2

Product Codes/Lot Numbers:

Lot # NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0254-2022

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