The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0150-2021·Announced 2020-12-23

Taro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity

Taro Pharmaceuticals is recalling CVS Health Athlete's Foot Cream because an unknown degradation impurity was detected slightly above the specification limit.

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: The agency classification is FDA Class II, which maps to a severity score of 4 (Severe) per the rubric, as it indicates a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 64,692 1-ounce tubes of CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%. The product is identified by Lot # A873430336 and an expiration date of December 2020. It was distributed nationwide in the USA and Canada.

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

Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
CLOTRIMAZOLE 1% (CLOTRIMAZOLE)
Brand
CLOTRIMAZOLE 1%
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — Topical Antifungal
Hazard

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 (2)

  • Lot #: A873430336
  • Exp Dec-2020

UPCs (1)

  • 0050428367933

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 →

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