Recalls / Class II
Class IID-0220-2026
Product
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
- Brand name
- Ganirelix Acetate
- Generic name
- Ganirelix Acetate
- Active ingredient
- Ganirelix Acetate
- Route
- Subcutaneous
- NDC
- 70748-274
- FDA application
- ANDA216075
- Affected lot / code info
- Lot #: WB00006, Exp 12/31/2026
Why it was recalled
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 5801 Pelican Bay Blvd, Suite 500, Naples, Florida 34108-2755
Distribution
- Quantity
- 32736 vials
- Distribution pattern
- FL, MA, MI & OH
Timeline
- Recall initiated
- 2025-11-13
- FDA classified
- 2025-12-08
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0220-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.