Why it was recalled
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Product description
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Lot numbers, UPCs & expiration codes
Lot #: WB00006, Exp 12/31/2026
Where it was sold
FL, MA, MI & OH
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-0220-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 13, 2025
- FDA report date
- Dec 17, 2025
- Quantity
- 32736 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0220-2026, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 97990
- Address
- 5801 Pelican Bay Blvd
- Address (line 2)
- Suite 500
- Code information
- Lot #: WB00006, Exp 12/31/2026
- Postal code
- 34108-2755
- Report date
- Dec 17, 2025
- Product type
- Drugs
- Recall number
- D-0220-2026
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 32736 vials
- Reason for recall
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
- Distribution pattern
- FL, MA, MI & OH
- Recall initiation date
- Nov 13, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 8, 2025