US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
US Pharmaceuticals Inc. is recalling 305 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests.
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 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 criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
US Pharmaceuticals Inc. is recalling 305 cases of Maximum Strength Hydrocortisone Cream (Hydrocortisone Cream), 1 OZ (28 g) tubes. The product is distributed by Walgreen Co. and was distributed 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, 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 this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
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
- 305
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 (1)
- 311917182452
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
Same brand · MAXIMUM STRENGTH HYDROCORTISONE CREAM
- ModerateUS Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues
FDA (Drugs) · 2019-08-21
Same manufacturer · US Pharmaceuticals Inc.
See all →- ModerateCVS Healing Ointment Recalled for Low Weight Fill Tubes
FDA (Drugs) · 2020-12-09
- ModerateUS Pharmaceuticals Recalls Kool Comfort Cooling Pain Relief Due to Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateUS Pharmaceuticals Recalls Intensive Healing Eczema Lotion for Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateCVS Health Glycerin Suppositories Recalled for Water Quality Issues
FDA (Drugs) · 2019-08-21
- ModerateUS Pharmaceuticals Recalls Soothe&Cool Protect Moisture Guard Skin Protectant
FDA (Drugs) · 2019-08-21
Same hazard · manufacturing deviation
See all →- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
- ModerateiVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance
FDA (Drugs) · 2026-05-06
- ModerateFurosemide tablets recalled for presence of N-nitroso impurity
FDA (Drugs) · 2026-04-29