Clobetasol Propionate Emollient Cream 0 — Class III drug recall D-0515-2019
Terminated recall by Akorn Inc, reported 2019-02-27, distributed nationwide. Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability stu
| Recall number | D-0515-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2019-01-25 |
| Classified | 2019-02-20 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-11-03 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 50383-0270-30, 50383-0270-60 |
| Expiration dates | 2019-04-15, 2019-04-16, 2019-04-19 |
Product
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
Reason for recall
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
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-0515-2019. 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.