Rapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations
Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.
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 FDA classified this as Class II with no reported illnesses or injuries. CGMP deviations alone, without evidence of product contamination or harm, do not meet the threshold for High or Severe per the rubric; this is a precautionary manufacturing-compliance recall.
Plain-English summary
Kenil Healthcare Private Limited, the manufacturer of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream, is recalling 10,000 tubes due to Current Good Manufacturing Practice (CGMP) deviations. The affected product is a 2 oz (60g) tube with Lot SP26A and an expiration date of 09/30/2026 (NDC 55758-420-02).
The cream was distributed in Delaware and North Carolina. The recall was initiated on April 24, 2025, and the firm notified customers via email, fax, letter, press release, telephone, and direct visits. The FDA classified this recall as Class II on May 19, 2025.
Consumers who have this product should stop using it and contact Pharmadel LLC, the distributor (located in New Castle, Delaware), for instructions on return or disposal. For more information, visit the FDA's drug safety website or contact the recalling firm directly.
The recalled product
- Product
- RAPIDOL (HYDROCORTISONE)
- Brand
- RAPIDOL
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Affected units
- 10,000
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
Part of a larger recall action
This product is one of 20 recalled by KENIL HEALTHCARE PRIVATE LIMITED 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.
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