Gynazole-1 — Class II drug recall D-0081-2024
Ongoing recall by Padagis US LLC, reported 2023-11-08, distributed nationwide. Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hy
| Recall number | D-0081-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Padagis US LLC, Minneapolis, MN, United States |
| Recall initiated | 2023-09-28 |
| Classified | 2023-10-31 |
| Reported by FDA | 2023-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 10,512 cartons |
| NDC | 45802-0396, 45802-0396-01, 45802-0396-02 |
| Lot numbers | 164185 |
| Expiration dates | 2024-04 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0081-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.