Lower risk Drug recall · FDA · Published February 6, 2025

Padagis Estradiol Gel Recall: Defective Container May Allow Ethanol Loss

Padagis recalls estradiol gel 0.1% (0.25 mg/g) due to potential ethanol loss from unsealed packets. This is a prescription-only product with a specific lot number and expiration date.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0246-2025Drug Padagis ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmPadagis US LLC3940 Quebec Ave N · Minneapolis, MN 55427-1244

✎ GovInfoNow plain-language explainer

Padagis is recalling estradiol gel that may have unsealed packets, risking ethanol loss. This could affect prescription users who need to follow proper storage and handling to prevent product degradation. Read more at govinfonow.com/recall/32295-padagis-estradiol-gel-recall-defective-container-may-allow-ethanol-loss.

Source Summary by GovInfoNow · govinfonow.com/recall/32295-padagis-estradiol-gel-recall-defective-container-may-allow-ethanol-loss · Updated August 17, 2026 · FDA enforcement record: FDA #D-0246-2025

Cite this page

“Padagis Estradiol Gel Recall: Defective Container May Allow Ethanol Loss.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32295-padagis-estradiol-gel-recall-defective-container-may-allow-ethanol-loss. Based on FDA recall #D-0246-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0246-2025%22&limit=1).

Padagis US LLC voluntarily recalled Estradiol Gel, 0.1%, 30 packets per carton on Feb. 6, 2025, according to the FDA. The recall addresses defective containers that may not be fully sealed, potentially causing ethanol loss. Owners should contact Padagis for a remedy.

How to tell if you have it

Brand: Padagis
Product: Estradiol Gel, 0.1%, 0.25 mg/g
Packaging: 30 packets per carton
NDC: 45802-0134-30
Lot #: 193109
Expiration Date: 07/31/2026
Quantity: 4944 cartons
Distribution: Nationwide in the USA

The hazard

Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Padagis US LLC has had 7 other recalls since Dec. 27, 2021. Recent similar recalls include ANI Pharmaceuticals Estradiol Gel (May 12, 2026), Amneal Estradiol Gel (Sept. 8, 2026), and Sun Pharmaceutical Diclofenac Gel (Jan. 27, 2026).

How to tell if you have this one

Check for the lot number 193109 on the packaging. The product is a prescription-only gel with 30 packets per carton, manufactured by Padagis in Yeruham, Israel, and expires July 31, 2026.

Brand
Padagis
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Container Seal
Inspect the gel packets for signs of being unsealed or damaged.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 27 days after the firm started it.

Feb 6, 2025Firm started the recall
Feb 21, 2025FDA classified it Class II
Mar 5, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Padagis recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32295-padagis-estradiol-gel-recall-defective-container-may-allow-ethanol-loss">Padagis Estradiol Gel Recall: Defective Container May Allow Ethanol Loss (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0246-2025 (February 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0246-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.