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, Man

Ganirelix Acetate Injection Recall Summary Lupin Pharmaceuticals is recalling Ganirelix Acetate Injection (250 mcg/0.5mL) in single-dose prefilled syringes because the product contains higher levels of an impurity called acrylic acid adduct than allowed by specifications. The affected batches were distributed in Florida, Massachusetts, Michigan, and Ohio. This is a Class I recall, which means use of the product could cause serious harm or death.

Recalling firm

Lupin Pharmaceuticals Inc.

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

Reason

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

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2025-11-13

Status

Ongoing

Areas affected

FL, MA, MI, OH

Distribution

FL, MA, MI & OH

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/5940db1d-2c03-4aca-aa56-3da8a4a63f25