FDA Drug recall D-0025-2015
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By…
- FDA Drug
- Class III
- terminated
- Published 2014-10-22
On 2014-10-22 the FDA classified a Class III recall of Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By… by Valeant Pharmaceuticals International, citing subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0025-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-10-02 |
| Published | 2014-10-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals International |
| Distribution | US |
Product
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
Reason
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Identifiers
| code_info | Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0025-2015%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.