FDAClass IIMarch 5, 2025

Estradiol Gel recall

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

Why was Estradiol Gel recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 193109; Exp. 07/31/2026

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
Recalling firm
Padagis US LLC
Quantity
4944 cartons
Distribution
Nationwide in the USA
Recall date
March 5, 2025
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls