Antifungal Cream Recalled

Padagis US is recalling 10,512 cartons of Gynazole-1 vaginal cream because the product formulation is incorrect. According to the November 8, 2023, US Food and Drug Administration (FDA) Enforcement Report, the product was manufactured with hydrophilic colloidal silica rather than hydrophobic colloidal silica.

The recall affects Gynazole-1 (butoconazole nitrate) vaginal cream, 2%, 1 prefilled applicator per carton (NDC 45802-396-01), from lot 164185 (Exp. 4/24). The product was manufactured by Padagis, Yeruham, Israel, and distributed by Padagis, Allegan, Michigan, throughout the US.

Padagis US voluntarily initiated the recall September 28, 2023. On October 31, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Gynazole-1 is a prescription vaginal cream indicated for the treatment of vulvovaginal candidiasis in nonpregnant women.