The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0247-2022·Announced 2021-11-24

LOTRIMIN AF Miconazole Nitrate Powder Spray Recall for Benzene Contamination

Bayer Healthcare Pharmaceuticals is recalling LOTRIMIN AF Jock Itch Powder Spray (4.6 oz, Miconazole Nitrate 2%) because certain lots contain benzene, a chemical contaminant.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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: The FDA has classified this recall as Class I, which per the rubric requires a minimum score of 4. The presence of benzene—a known carcinogen—in a topical drug product represents a serious health hazard requiring immediate action.

Plain-English summary

Bayer Healthcare Pharmaceuticals Inc. is recalling LOTRIMIN AF Jock Itch Powder Spray containing Miconazole Nitrate 2% in 133g (4.6 oz) cans. The product has been identified as containing benzene, a chemical contaminant.

The affected product was distributed nationwide in the United States, Puerto Rico, Canada, and Mexico through various retail channels. The affected lot numbers are CV018TV (expiration 11/30/2021), CV01A71 (1/31/2022), CV01CK4 (4/30/2022), TN0023G (12/31/2022), TN006TC (1/31/2023), TN007TG (3/31/2023), TN008CZ (4/30/2023), and TN008CY (4/30/2023).

Consumers who have purchased this product should stop using it immediately. Those with questions or concerns should contact their healthcare provider. The product is distributed by Bayer Healthcare LLC in Whippany, New Jersey (NDC 11523-4140-2, UPC 3 11017 41031 8).

The recalled product

Product
LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Category
Drug — Topical Antifungal
Hazard
Affected units
4,546,152

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 (16)

  • Lot # CV018TV
  • 11/30/2021
  • CV01A71
  • 1/31/2022
  • CV01CK4
  • 4/30/2022
  • TN0023G
  • 12/31/2022
  • TN006TC
  • 1/31/2023
  • TN007TG
  • 3/31/2023
  • TN008CZ
  • 4/30/2023
  • TN008CY
  • 4/30/2023.

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 →

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