Class IIOngoing

Ganirelix Acetate Injection recall

FDA recall D-0220-2026 · initiated Nov 13, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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
Recalling company: Lupin Pharms
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: FL, MA, MI & OH
Initiated: Nov 13, 2025
FDA report date: Dec 17, 2025

This recall is linked to a product we cover: Ganirelix Acetate →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0220-2026 ↗

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