Clobetasol Propionate Ointment — Class II drug recall D-0795-2023
Ongoing recall by Akorn, Inc., reported 2023-06-07, distributed nationwide. CGMP Deviations: Firm went out of business and could no longer continue stability studies.
| Recall number | D-0795-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Gurnee, IL, United States |
| Recall initiated | 2023-04-26 |
| Classified | 2023-06-01 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
Product
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Reason for recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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-0795-2023. 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.