Estradiol Gel — Class II drug recall D-0246-2025
Completed recall by Padagis US LLC, reported 2025-03-05, distributed nationwide. Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the p
| Recall number | D-0246-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Padagis US LLC, Minneapolis, MN, United States |
| Recall initiated | 2025-02-06 |
| Classified | 2025-02-21 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 4,944 cartons |
| Reason classes | packaging |
| NDC | 45802-0134-30 |
| Lot numbers | 193109 |
| Expiration dates | 2026-07-31 |
Product
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Reason for recall
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
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-0246-2025. 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.