PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: March 5, 2025 Initiated: February 6, 2025 #D-0246-2025

Product Description

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.

Details

Recalling Firm
Padagis US LLC
Units Affected
4944 cartons
Distribution
Nationwide in the USA
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
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. Recalled by Padagis US LLC. Units affected: 4944 cartons.
Why was this product recalled?
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 5, 2025. Severity: Moderate. Recall number: D-0246-2025.