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 openFDA enforcement API. 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.