The Recall Desk
ModerateFDA (Drugs)·D-0159-2021·Announced 2020-12-23

Taro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity

Taro Pharmaceuticals is recalling specific lots of Clotrimazole Cream USP 1% because an unknown degradation impurity was detected slightly above the specification limit.

What this means for you

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, and the source text indicates the impurity was detected only slightly above the specification limit without reports of illness or injury, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 40,896 tubes of Athlete's Foot Cream, Clotrimazole Cream USP, 1%, 1 oz (30 g). The product is identified by Lot # B870130838 and an expiration date of January 2021. The recall was initiated because an unknown degradation impurity was detected slightly above the specification limit in the cream.

The affected product was distributed nationwide in the USA and Canada. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers with this specific product should stop using it and contact Taro Pharmaceuticals or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0
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 (4)

  • Lot#: B870130838
  • Exp Jan 2021 70
  • 200 63
  • 252

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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