Cura Hongos Antifungal Products Recalled for CGMP Deviations

Two topical antifungal products distributed by Pharmadel LLC are being voluntarily recalled due to current good manufacturing practice (CGMP) deviations, according to the US Food and Drug Administration (FDA). The affected products include Cura Hongos antifungal 1% clotrimazole topical lotion in 0.76 fl oz (22.5 mL) bottles and Cura Hongos antifungal cream 1% clotrimazole in 2 oz (56.7 g) tubes. The impacted lots—SP31A (lotion, exp. 09/30/2026) and SP23A (cream, exp. 03/31/2026)—were manufactured in India and distributed in Delaware and North Carolina.

Both recalls were initiated voluntarily by the manufacturer, Kenil Healthcare Private Limited, based in Mehsana, India. A total of 10 128 bottles of the lotion and 10 788 tubes of the cream are involved in the Class II recall, indicating that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences. Notification to consignees was issued through multiple channels, including email, fax, letters, and telephone communication. The recall remains ongoing as of May 28, 2025.

Cura Hongos products contain 1% clotrimazole, an antifungal agent commonly used to treat topical fungal infections such as athlete’s foot, jock itch, and ringworm. Pharmacists should advise patients to check their products against the recalled lot numbers and report any adverse events to the FDA’s MedWatch program.