Drug Recall: CURA HONGOS Antifungal Lotion Due to Manufacturing Deviations
CURA HONGOS antifungal lotion is being recalled due to manufacturing process deviations. The recall affects 10,128 bottles 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 a voluntary, firm-initiated recall due to CGMP manufacturing deviations. FDA Class II classification combined with the voluntary, precautionary nature of the recall aligns with Moderate severity per the rubric.
Plain-English summary
CURA HONGOS is a 1% clotrimazole topical antifungal lotion in 0.76 fl oz bottles, manufactured by Kenil Healthcare Private Limited in India and distributed in the United States by Pharmadel LLC, based in Delaware.
The manufacturer voluntarily initiated a recall on April 24, 2025, due to deviations from Current Good Manufacturing Practice (CGMP) standards identified in the manufacturing process.
Lot SP31A with an expiration date of September 30, 2026, was affected. The recall involved 10,128 bottles distributed in Delaware and North Carolina. The recall was terminated on February 19, 2026.
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
- 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 SP31A
- Exp Date: 09/30/2026
Distribution
Distributed in 2 states:
- DE
- NC
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