United StatesGanirelix Acetate Injection, 250 mcg/0.5 mL single‑dose sterile prefilled syringe (27 gauge by 1/2" needle), NDC 70748-274-01, Lot WB00006, exp. 12/31/2026, manufactured for Lupin Pharmaceuticals Inc., is being recalled (32,736 vials) in Florida, Massachusetts, Michigan and Ohio. The product was recalled because testing showed out-of-specification results for a Ganirelix acetate acrylic acid adduct impurity (impurities/degradation specifications).
What's being recalled
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
Recalling firm: Lupin Pharmaceuticals Inc., Naples, FL, United States.
How to identify it
Lot #: WB00006, Exp 12/31/2026
The hazard
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
FL, MA, MI & OH
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)