The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0422-2025·Announced 2025-05-28

Antifungal Drug Recalled for Manufacturing Process Deviations

Pharmadel LLC is recalling CURA HONGOS 1% Clotrimazole topical lotion due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The voluntary recall affects approximately 10,128 bottles distributed in Delaware and North Carolina.

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 FDA Class II with no reported illnesses or injuries. The hazard (CGMP deviations) is a manufacturing process issue without documented adverse health consequences, fitting the criteria for Moderate severity.

Plain-English summary

Pharmadel LLC, New Castle, Delaware, is voluntarily recalling CURA HONGOS Antifungal 1% Clotrimazole Topical Lotion (0.76 fl oz / 22.5 mL bottles) due to Current Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process. The product is made in India by KENIL HEALTHCARE PRIVATE LIMITED.

The recalled product includes Lot SP31A with an expiration date of 09/30/2026, and approximately 10,128 bottles were distributed to Delaware and North Carolina. The FDA classified this as a Class II recall on May 19, 2025, and the firm initiated the recall on April 24, 2025.

Consumers who have purchased this product should stop using it. No illnesses or injuries related to this recall have been reported. Consumers with questions may contact the recalling firm or their healthcare provider for further guidance.

The recalled product

Product
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
Manufacturer
KENIL HEALTHCARE PRIVATE LIMITED
Category
Drug — Topical Antifungal
Hazard
Affected units
10,128

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 SP31A
  • Exp Date: 09/30/2026

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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