Class IIReported 2025-12-17

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

Reason for Recall

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

Recall Number

D-0220-2026

Classification

Class II

Status

Ongoing