Key Takeaway

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 by Padagis US LLC was recalled on February 6, 2025. The hazard: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

FDA Drug 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

Recalled: February 6, 2025 ~4944 cartons units affected D-0246-2025

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Padagis US LLC

Minneapolis, MN, United States

View all 7 recalls by Padagis US LLC →

Distribution

Nationwide in the USA

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Frequently Asked Questions

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