November 06, 2020
The recall affects 15-gram tubes of hydrocortisone butyrate cream, 0.1% (NDC 68682-270-15), from lots 18125C (Exp. 9/20), 19079B (Exp. 5/21), 19142B (Exp. 9/21), and 19167B (Exp. 10/21). The product was manufactured for Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals, by Ferndale Laboratories Inc. and distributed within the United States.
Bausch Health Companies voluntarily initiated the recall July 13, 2020. On October 26, 2020, the FDA designated the recall Class II. Use of products under Class II recalls could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Hydrocortisone butyrate cream is a prescription topical corticosteroid used to treat eczema, dermatitis, rash, and other skin conditions.