The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0428-2025·Announced 2025-05-28

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.

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 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
Category
Drug — Topical / Over-the-Counter
Hazard
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

Distributed in 2 states:

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.

See all 20 products in this recall →

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