Drug recalls

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-…

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

Class IICompletedD-0246-2025
Status
Completed
City
Minneapolis
State
MN
Country
United States
Classification
Class II
Product type
Drugs
Event ID
96245
Recalling firm
Padagis US LLC
Address 1
3940 Quebec Ave N
Address 2
N/A
Postal code
55427-1244
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA
Recall number
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
Product quantity
4944 cartons
Reason for recall
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Recall initiation date
20250206
Center classification date
20250221
Report date
20250305
Code info
Lot # 193109; Exp. 07/31/2026
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.