Estradiol Gel recall
FDA recall D-0246-2025 · initiated Feb 6, 2025
Padagis US LLC recalled Estradiol Gel in Feb 2025 — an FDA Class II recall (D-0246-2025) because Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4944 cartons
Details
- 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 company
- Padagis US
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 6, 2025
- FDA report date
- Mar 5, 2025
Frequently asked
- Was Estradiol Gel recalled?
- Padagis US LLC recalled Estradiol Gel in Feb 2025 — an FDA Class II recall (D-0246-2025) because Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Estradiol Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0246-2025 was: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
- Is a recalled Estradiol Gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Estradiol Gel are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # 193109; Exp. 07/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0246-2025.