Gynazole-1 Vaginal Cream (Padagis) – incorrect product formulation (2023)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01
Brand
Padagis US LLC
Lot Codes / Batch Numbers
Lot#: 164185, Exp. Date 4/2024
Products Sold
Lot#: 164185, Exp. Date 4/2024
Padagis US LLC is recalling Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, pa due to Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required b. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026