The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0157-2021·Announced 2020-12-23

Taro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity

Taro Pharmaceuticals is recalling Best Choice Clotrimazole Cream USP 1% 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 agency classified this as an FDA Class II recall. The source text does not report any illnesses, injuries, or hospitalizations, and the impurity was only slightly above the specification limit, fitting the criteria for a moderate severity rating.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g). The product is distributed by Valu Merchandisers and was made in Canada. The recall involves 11,088 1 oz tubes with Lot # D867331087 and an expiration date of March 2021.

The recall was initiated because an unknown degradation impurity was detected slightly above the specification limit in the cream. The agency has classified this as a Class II recall.

The product was distributed nationwide in the USA and Canada. Consumers should stop using the recalled product and return it to the place of purchase or contact the recalling firm for instructions.

The recalled product

Product
Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1
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 (5)

  • Lot #: D867331087
  • Exp Mar
  • 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 →

Related recalls

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

See all →

Same hazard · impurity

See all →

Similar recalls