Hydrocortisone Butyrate Cream (Bausch) – Subpotent Drug (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15
Brand
Bausch Health Companies, Inc.
Lot Codes / Batch Numbers
Lot #: 18125C, Exp. Date 09/2020, 19079B, Exp. Date 5/2021, 19142B, Exp. Date 09/2021, 19167B, Exp. Date 10/2021
Products Sold
Lot #: 18125C, Exp. Date 09/2020; 19079B, Exp. Date 5/2021; 19142B, Exp. Date 09/2021; 19167B, Exp. Date 10/2021
Bausch Health Companies, Inc. is recalling Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceutic due to SUBPOTENT DRUG. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
SUBPOTENT DRUG
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026