The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0158-2021·Announced 2020-12-23

Taro Recalls TopCare Clotrimazole Cream Due to Impurity

Taro Pharmaceuticals is recalling TopCare Clotrimazole 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 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 score (2) in the absence of reported injuries or more severe hazards.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling TopCare (Clotrimazole) Cream USP, 1%, Antifungal. The recall involves a specific lot of the product, identified as Lot # D867331277 with an expiration date of March 2021. The product is distributed by Topco Associates LLC in Elk Grove Village, IL, and 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 Clotrimazole Cream USP 1%. This is a Class II recall, which indicates that 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 who have purchased this specific lot of TopCare Clotrimazole Cream should stop using it and contact Taro Pharmaceuticals or their healthcare provider for further instructions. The product is an over-the-counter antifungal cream used for athlete's foot.

The recalled product

Product
TOPCARE (CLOTRIMAZOLE)
Brand
TOPCARE
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — OTC 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#: D867331277
  • Exp Mar 2021 70
  • 200 63
  • 252

UPCs (1)

  • 036800495692

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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