CLASS III Drug recall · Reported 22 Oct 2014 · FDA Enforcement Report
Locoid (hydrocortisone butyrate 0.1%), Cream recalled
Valeant Pharmaceuticals International is recalling Locoid (hydrocortisone butyrate 0.1%), Cream, distributed nationwide in the US. The recall was initiated on 2 Oct 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0026-2015
- FDA event ID
- 69359
- Recalling firm
- Valeant Pharmaceuticals International, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Oct 2014
- FDA classified
- 16 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Oct 2014 | Recall initiated by company | |
| 16 Oct 2014 | Classified by FDA | +14 days |
| 22 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Which lots are affected?
Lot number 13052B, Exp. 03/2015, NDC16781-382-15
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 69359| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Hydrocortisone Butyrate Cream recalled by Valeant Pharmaceuticals | Valeant Pharmaceuticals International | Potency & Assay | Nationwide |
More recalls from Valeant Pharmaceuticals International
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone Butyrate Cream recalled by Valeant Pharmaceuticals | Valeant Pharmaceuticals International | Potency & Assay | Nationwide |