Clotrimazole and Betamethasone Dipropionate Cream USP — Class III drug recall D-0727-2022
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2022-04-06, distributed in NY. Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay
| Recall number | D-0727-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2022-02-25 |
| Classified | 2022-03-29 |
| Reported by FDA | 2022-04-06 |
| Terminated | 2024-09-09 |
| Distributed | NY |
| Quantity | 768 tubes |
| Reason classes | potency, specification failure |
| NDC | 51672-4048, 51672-4048-01, 51672-4048-06 |
| Lot numbers | AC33883 |
| Expiration dates | 2023-06-20 |
Product
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
Reason for recall
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0727-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.