February 2025 FDA Recall Drug by Padagis Us Llc
D-0246-2025 - Defective Container

This Class II drug recall was voluntarily initiated by Padagis Us Llc on February 6, 2025 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0246-2025

Reason for Recall
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Initiated
02-06-2025
Reported
03-05-2025
Quantity
4944 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96245
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Padagis US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 193109; Exp. 07/31/2026