Gynazole 1 Butoconazole Vaginal Cream Recalled for Formulation Error
Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall. Manufacturing formulation error involving an incorrect chemical ingredient in a drug product constitutes a risk-of-harm situation, fitting the rubric criterion for this score.
Plain-English summary
Padagis US LLC is recalling Gynazole 1 (butoconazole nitrate 2%) vaginal cream due to a manufacturing formulation error. The product was manufactured using hydrophilic colloidal silica instead of hydrophobic colloidal silica as required by the manufacturing process.
The recall involves 10,512 cartons with Lot #164185 (expiration April 2024), distributed nationwide in the United States. Gynazole 1 is a prescription vaginal antifungal cream.
The recalled product
- Product
- GYNAZOLE 1 (BUTOCONAZOLE NITRATE)
- Brand
- GYNAZOLE 1
- Manufacturer
- Padagis US LLC
- Category
- Drug — Vaginal Antifungal
- Affected units
- 10,512
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 164185
- Exp. Date 4/2024
Distribution
Distributed nationwide across the United States.
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