US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals is recalling Maximum Strength Hydrocortisone Cream with Aloe due to out-of-specification results in the purified water used during manufacturing.
What this means for you
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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (water quality) rather than a confirmed high-risk pathogen or structural defect, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
US Pharmaceuticals Inc. is recalling 3,114 cases of Maximum Strength Hydrocortisone Cream with Aloe (Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube). The product is distributed by Walgreen Co. and was distributed nationwide in the USA. The recall involves Lot #63J17 (EXP 07/2019) and Lot #11P17 (EXP 11/2019).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, out-of-specification results were found for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the manufacturer for further instructions.
The recalled product
- Product
- MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE (HYDROCORTISONE CREAM)
- Brand
- MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Corticosteroid
- Affected units
- 3,114
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 (2)
- Lot #63J17 EXP 07/2019
- 11P17 EXP 11/2019
UPCs (2)
- 0311917179353
- 311917179353
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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