RecallRadar

FDA Drug recall D-0727-2022

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd

On 2022-04-06 the FDA classified a Class III recall of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd by Taro Pharmaceuticals U, citing failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0727-2022
ClassificationClass III
Statusterminated
Initiated2022-02-25
Published2022-04-06
Last updated2026-09-13 11:52 UTC
CompanyTaro Pharmaceuticals U
DistributionNY

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

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Identifiers

ndc51672-4048-1
ndc51672-4048-6
code_infoLot #: AC33883, Exp. Date June 2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0727-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.