Hydrocortisone Cream (US Pharmaceuticals) – Water Contamination Risk (2019)
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 Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6
Brand
US Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot #56J17 EXP 07/2019
Products Sold
Lot #56J17 EXP 07/2019
US Pharmaceuticals Inc. is recalling Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgree due to CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufactu. 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
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
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