The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0634-2026·Announced 2026-06-24

Cura Hongos clotrimazole cream recalled over manufacturing practice deviations

Cura Hongos Crema Antifungica, clotrimazole 1%, in 2 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 84 tubes affected.

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: FDA Class II recall arising from inspection-observed manufacturing deviations with no product defect or consequence described, which fits the Moderate band.

Plain-English summary

Cura Hongos, Crema Antifungica, clotrimazole 1%, 2 oz (57 g) tubes, distributed by Pharmadel LLC of New Castle, Delaware and made in India, UPC 8 52924 00683 1, is being recalled. The action covers 84 tubes.

The stated reason is CGMP deviations and deficiencies observed during an FDA inspection. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.

The affected lot is 0003, within expiry. Distribution was USA nationwide.

Consumers who have the affected lot should stop using it and follow the instructions issued by the firm.

The recalled product

Product
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
Manufacturer
Dabur India Limited
Category
Drug — Topical antifungal cream
Hazard
Affected units
84

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# 0003
  • within expiry

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Dabur India 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 14 products in this recall →

Related recalls

Same manufacturer · Dabur India Limited

See all →

Same hazard · cgmp deviation

See all →

Similar recalls