# FDA recall D-0081-2024

> **Padagis US LLC** · Class II · drug recall initiated 2023-09-28.

## 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

## Reason for recall

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0081-2024
- **Recalling firm:** Padagis US LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-09-28
- **Report date:** 2023-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2024

## Citation

> AI Analytics. FDA recall D-0081-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0081-2024. Source: US FDA. Licensed CC0.

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