Why it was recalled
Defective Container; packets were found to be either empty or partially full.
Product description
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Lot numbers, UPCs & expiration codes
Lot M251109, exp Nov 2027
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-0543-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 12, 2026
- FDA report date
- May 27, 2026
- Quantity
- 3964 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ANI Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0543-2026, exactly as published.
Show all FDA fields
- City
- Baudette
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 98947
- Address
- 210 W Main St
- Code information
- Lot M251109, exp Nov 2027
- Postal code
- 56623-2467
- Report date
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0543-2026
- Classification
- Class II
- Recalling firm
- ANI Pharmaceuticals, Inc.
- Product quantity
- 3964 Cartons
- Reason for recall
- Defective Container; packets were found to be either empty or partially full.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 12, 2026
- Initial firm notification
- Letter
- Center classification date
- May 20, 2026