The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0151-2021·Announced 2020-12-23

Taro Recalls Clotrimazole Cream Due to Unknown Impurity

Taro Pharmaceuticals is recalling Equate Athlete's Foot cream because an unknown impurity was detected above specification limits.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where adverse health consequences are temporary or medically reversible, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 481,896 tubes of Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream. The product is available in 0.5 oz and 2 oz sizes and was distributed nationwide in the USA and Canada by Walmart Inc.

The recall was initiated because an unknown degradation impurity was detected slightly above the specification limit in the cream. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund. Specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
CLOTRIMAZOLE (CLOTRIMAZOLE)
Brand
CLOTRIMAZOLE
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — Topical Antifungal
Hazard
Affected units
481,896

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 (12)

  • Lot#: a)A873430371
  • Exp Dec-2020
  • B870030918
  • Exp Jan-2021
  • C868330918
  • Exp Feb-2021 b) A873430406
  • A873530406
  • A873630406
  • B870030635
  • B870130867
  • C868330867
  • Exp Feb-2021

UPCs (1)

  • 0681131003797

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Taro Pharmaceuticals U.S.A., 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 10 products in this recall →

Related recalls

Same brand · CLOTRIMAZOLE

Same manufacturer · Taro Pharmaceuticals U.S.A., Inc.

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Same hazard · impurity

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