Antifungal Cream Recalled for Manufacturing Deviations
Kenil Healthcare is recalling CURA HONGOS Antifungal Cream (Clotrimazole 1%, 2 oz tubes) distributed in Delaware and North Carolina due to CGMP (Current Good Manufacturing Practice) deviations detected during manufacturing.
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 recall is FDA Class II and was initiated voluntarily by the firm for CGMP deviations. No illnesses or injuries are reported in the source text, and the hazard is procedural/precautionary rather than an identified pathogen or structural defect, warranting a Moderate classification.
Plain-English summary
Kenil Healthcare Private Limited is recalling CURA HONGOS Antifungal Cream, Clotrimazole 1%, in 2 oz (56.7 g) tubes with UPC 8 997110 011052. The product was distributed by Pharmadel LLC in Delaware and North Carolina. A total of 10,788 tubes are affected. The specific lot is SP23A with an expiration date of 03/31/2026.
The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations discovered in the manufacturing process. This is a voluntary recall initiated by the firm.
Consumers who have purchased this product should stop using it and consult a healthcare provider if they have questions about whether they have been affected or about appropriate alternative treatments. The product should be returned to the place of purchase.
The recalled product
- Product
- CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 10,788
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 SP23A
- Exp Date: 03/31/2026
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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