Hydrocortisone Butyrate Cream 0 — Class III drug recall D-0025-2015
Terminated recall by Valeant Pharmaceuticals International, reported 2014-10-22, distributed nationwide. Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stabili
| Recall number | D-0025-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals International, Bridgewater, NJ, United States |
| Recall initiated | 2014-10-02 |
| Classified | 2014-10-16 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2015-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 34,218 tubes |
| Reason classes | potency, specification failure |
| NDC | 43478-0270-15 |
| Lot numbers | 13052C, 13156A |
| Expiration dates | 2015-03, 2015-08 |
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 for recall
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
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-0025-2015. 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.