Severity
Low
FDA Drug recall · Reported April 6, 2022
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Taro Pharmaceuticals U.S.A., Inc. recalled Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manu… - a low-severity action.
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manu… was recalled by Taro Pharmaceuticals U.S.A., Inc. in April 6, 2022. Reason: Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assa…. Check the official notice for the remedy. Verify recall #D-0727-2022 with the FDA Drug before acting.
The recall
Taro Pharmaceuticals U.S.A., Inc. issued this low-severity FDA Drug recall-Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assa….
Sourced from official FDA Drug enforcement records. Verify recall #D-0727-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0727-2022) was formally reported on April 6, 2022, with the manufacturer initiating the action on February 25, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Taro Pharmaceuticals U.S.A., Inc. is listed as the recalling firm, operating out of Hawthorne, NY. Federal records list the affected scope as 768 tubes.
The documented reason for this recall is: Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample Distribution data in the federal record shows the product reached: Product was distributed to one retail consignee in NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 1,360 cosmetics & personal care recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
768 tubes
Related Recalls
6
3 from same agency
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
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0727-2022 |
| Date reported | April 6, 2022 |
| Date initiated | February 25, 2022 |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc. |
| Firm location | Hawthorne, NY |
| Affected scope | 768 tubes |
| Distribution | Product was distributed to one retail consignee in NY. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 6, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.