Why it was recalled
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 193109; Exp. 07/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0246-2025
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Feb 6, 2025
- FDA report date
- Mar 5, 2025
- Quantity
- 4944 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-0246-2025, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Completed
- Country
- United States
- Event ID
- 96245
- Address
- 3940 Quebec Ave N
- Code information
- Lot # 193109; Exp. 07/31/2026
- Postal code
- 55427-1244
- Report date
- Mar 5, 2025
- Product type
- Drugs
- Recall number
- D-0246-2025
- Classification
- Class II
- Recalling firm
- Padagis US LLC
- Product quantity
- 4944 cartons
- Reason for recall
- Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 6, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2025