Padagis recalls Gynazole-1 vaginal cream due to incorrect silica formulation. This may cause irritation or other issues. Contact for return instructions.
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Padagis is recalling Gynazole-1 vaginal cream because it was made with hydrophilic silica instead of hydrophobic silica as required. This could lead to irritation or other issues for users.
The cream was made with hydrophilic silica instead of hydrophobic silica. This incorrect formulation could cause irritation or other issues when used.
People who have the recalled Gynazole-1 vaginal cream (2% butoconazole nitrate) from Padagis. Those with sensitive vaginal tissue may be at higher risk.
Check for the product name 'Gynazole-1', 2% butoconazole nitrate vaginal cream, 5.8g per pre-filled applicator, packaged in 1 per carton. The lot number is 164185 with an expiration date of April 2024.
Look for the product name 'Gynazole-1', 2% butoconazole nitrate vaginal cream, 5.8g per pre-filled applicator, packaged in 1 per carton.
The recall states the product was made with incorrect silica, which could cause irritation. It is not recommended for use.
Check for the product name 'Gynazole-1', 2% butoconazole nitrate vaginal cream, 5.8g per pre-filled applicator, packaged in 1 per carton with lot number 164185 and expiration date April 2024.
The recall does not specify a remedy, so contact Padagis for further instructions.
We’ve drafted a message you can send Padagis to request your refund or repair — edit it as you like.
Subject: Recall D-0081-2024 — Padagis Padagis Hello, I own a Padagis that is covered by recall D-0081-2024 from Padagis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
