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D-0246-2025Class II

Padagis US LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Padagis US LLC
Product type
Drug
Status
Completed
Report date
2025-03-05
Distribution
Nationwide in the USA
Firm state
MN
Product quantity
4944 cartons
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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

Code / lot info

Lot # 193109; Exp. 07/31/2026

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →