Skip to content
Back to recalls
Drug FDA Class II Completed Quality

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

Padagis US LLC Published Mar 5, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Padagis US LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

4944 cartons

Lot codes: 193109
Code info: Lot # 193109; Exp. 07/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 6, 2025
  2. Published
    Mar 5, 2025
Recall number
D-0246-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.