Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gynazole-1 Recalled by Padagis US LLC Due to Incorrect Product Formulation: Hydrophilic Colloidal Silica was used...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Padagis US LLC directly.
Affected Products
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
Quantity: 10,512 cartons
Why Was This Recalled?
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Padagis US LLC
Padagis US LLC has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report