Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/...
FDA Recall #D-0220-2026 — Class II — November 13, 2025
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
Reason for Recall
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Recalling Firm
Lupin Pharmaceuticals Inc. — Naples, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
32736 vials
Distribution
FL, MA, MI & OH
Code Information
Lot #: WB00006, Exp 12/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated