FDA Drug recall D-0515-2019
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only
- FDA Drug
- Class III
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class III recall of Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only by Akorn, citing failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0515-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-25 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Identifiers
| code_info | a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19 |
|---|
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-0515-2019%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.