Drug & medication recalls Moderate risk

Padagis US LLC recalls Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham,…

Recall date
February 6, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0246-2025
FDA classification
Class II
Brand / firm
Padagis US LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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