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Serious recall: Injury is possible or has been reported. Take action promptly.

Padagis US LLC 2025-03-05 Health serious FDA
Health · FDA · Recall #FDA-D-0246-2025

Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only,… Recall

Issued March 5, 2025 · Padagis US LLC

In March 2025, Padagis US LLC recalled the Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only,…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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

What you should do

  1. 1 Stop using Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Padagis US LLC to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Padagis US LLC
Category
Health
Recall date
March 5, 2025
Units affected
Not reported
Sold at
Nationwide in the USA
Recall number
FDA-D-0246-2025
Made in
United States
Issuing agency
FDA

In context

  • Padagis US LLC has 7 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 691st Health recall we've logged in 2025.
Read the official FDA notice

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