FDA Drug recall D-0246-2025
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-…
- FDA Drug
- Class II
- completed
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of 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-… by Padagis Us, citing defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0246-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-02-06 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Padagis Us |
| Distribution | US |
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
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Identifiers
| code_info | Lot # 193109; Exp. 07/31/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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FDA Drug · Class II · 2023-11-08 · Padagis Us - Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by…
FDA Drug · Class III · 2023-03-22 · Padagis Us
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0246-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.