US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals is recalling specific lots of Maximum Strength Hydrocortisone Cream with Aloe because the purified water used in manufacturing failed quality tests.
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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves manufacturing deviations in purified water quality (microbial/organic carbon) rather than a confirmed high-risk pathogen or reported illness, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
US Pharmaceuticals Inc. is recalling 1,223 cases of Maximum Strength Hydrocortisone Cream with Aloe (Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ). The product is distributed by Walgreen Co. and was sold nationwide in the USA. The recall involves Lot #11P17 and Lot #20P17, both with an expiration date of 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 these specific lots should stop using the product 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
- 1,223
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 #'s 11P17
- 20P17 EXP 11/2019
UPCs (2)
- 0311917179346
- 311917179346
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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