Lupin Pharmaceuticals Inc. initiated a recall of Ganirelix Acetate Injection on November 13, 2025. The recall is classified as Class II by the FDA. The affected product is Ganirelix Acetate Injection, 250 mcg per 0.5 mL, supplied as a single-dose sterile prefilled syringe with a 27 gauge by 1/2 inch needle, NDC 70748-274-01. It was manufactured for Lupin Pharmaceuticals Inc. of Naples, Florida, and manufactured by Lupin Limited in Nagpur, India.
The reason given for the recall is failed impurities and degradation specifications. Specifically, testing found an out of specification result for the ganirelix acetate acrylic acid adduct impurity. The recall status is listed as ongoing as of the reported date.
This action reflects a manufacturing specification finding as reported to the FDA. No additional details on distribution scope or patient impact were included in this event record. The recall identifier for this action is D-0220-2026.
Readers can consult the compound overview for general context on ganirelix.