Recalls / Class II

Class IID-0246-2025

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

Affected lot / code info

Lot # 193109; Exp. 07/31/2026

Why it was recalled

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

Recalling firm

Firm

Padagis US LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3940 Quebec Ave N, N/A, Minneapolis, Minnesota 55427-1244

Distribution

Quantity

4944 cartons

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2025-02-06

FDA classified

2025-02-21

Posted by FDA

2025-03-05

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0246-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.