Class II
Ongoing
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
This recall is currently active, issued December 17, 2025. It was issued by Lupin Pharmaceuticals Inc..
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- November 13, 2025
- Posted
- December 17, 2025
- Recall Number
- D-0220-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 32736 vials
- Firm Location
- Naples, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Distribution
FL, MA, MI & OH
Lot / Code Info
Lot #: WB00006, Exp 12/31/2026
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