Clotrimazole and Betamethasone Topical Cream Recalled for Failed Potency Specifications
Taro Pharmaceuticals recalls Clotrimazole and Betamethasone Dipropionate cream after a stability sample failed potency testing. The recall affects 768 tubes distributed to a retailer in New York, expiring June 2023. No illnesses have been reported.
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 FDA classified this as a Class III recall, which by definition indicates the product is not likely to cause adverse health consequences. No illnesses or injuries have been reported. The issue is a manufacturing specification failure rather than confirmed contamination, consistent with precautionary recalls classified as Moderate.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, in 15-gram tubes due to failed content uniformity specifications. During stability testing, a sample from lot AC33883 returned an out-of-specification result for the Betamethasone Dipropionate assay, indicating the active ingredient potency may not meet established standards.
The affected lot (AC33883, expiring June 2023) was distributed to a single retail consignee in New York, affecting approximately 768 tubes. The prescription cream was manufactured by Taro Pharmaceuticals Industries Ltd. in Haifa, Israel and distributed by Taro Pharmaceuticals U.S.A., Inc. in Hawthorne, New York.
No illnesses or adverse events have been reported. This is an FDA Class III recall.
The recalled product
- Product
- CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE)
- Brand
- CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Hazard
- improper-potency
- content-uniformity
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 #: AC33883
- Exp. Date June 2023
Distribution
Distributed in 1 state:
- NY
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