Hydrocortisone anti-itch cream recalled due to manufacturing practice deviations
RAPIDOL Maximum Strength Hydrocortisone 1% Anti-Itch Cream is being recalled due to manufacturing practice deviations. The recall affects 10,000 tubes distributed in Delaware and North Carolina.
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: This is an FDA Class II recall initiated voluntarily due to CGMP deviations with no reported illnesses, injuries, or specific product defects. Per the severity rubric, voluntary recalls without reported harm are classified as Moderate.
Plain-English summary
RAPIDOL Maximum Strength Hydrocortisone 1% Anti-Itch Cream, a topical corticosteroid, is being recalled. The affected product is sold in 2-ounce (60-gram) tubes with lot number SP26A, expiring September 30, 2026. The product is identified by NDC 55758-420-02 and UPC 810096771582.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations during the manufacturing process. No specific product defects or illnesses have been reported.
The recall affects approximately 10,000 tubes that were distributed in Delaware and North Carolina. Kenil Healthcare Private Limited initiated the recall voluntarily on April 24, 2025. The FDA terminated the recall on February 19, 2026. Consumers who have purchased this product should stop using it and contact their retailer or healthcare provider for guidance.
The recalled product
- Product
- RAPIDOL (HYDROCORTISONE)
- Brand
- RAPIDOL
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — OTC Anti-itch Cream
- Hazard
- cgmp-deviation
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 SP26A
- Exp: 09/30/2026
UPCs (1)
- 810096771582
Distribution
Distributed in 2 states:
- DE
- NC
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