US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals is recalling 651 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (water quality) without reported illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
US Pharmaceuticals Inc. is recalling 651 cases of Maximum Strength Hydrocortisone Cream (Hydrocortisone 1% / Anti-Itch Cream, 2 OZ tube). The product is distributed by Walgreen Co. and was sold nationwide in the USA. The specific lot affected is #56J17 with an expiration date of 07/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water utilized in the manufacturing process produced out-of-specification results for either total microbial count or total organic carbon. This indicates that the water used to make the cream did not meet required quality standards.
Consumers who have purchased this specific lot of Maximum Strength Hydrocortisone Cream should stop using it and return it to the place of purchase for a refund. The product is identified by NDC #0363-0638-04 and UPC 3 11917 18247 6.
The recalled product
- Product
- MAXIMUM STRENGTH HYDROCORTISONE CREAM (HYDROCORTISONE CREAM)
- Brand
- MAXIMUM STRENGTH HYDROCORTISONE CREAM
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Corticosteroid
- Affected units
- 651
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #56J17 EXP 07/2019
UPCs (2)
- 0311917182476
- 311917182476
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by US Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
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