Reported Dec 17, 2025 · Ongoing
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only,…
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 5801 Pelican Bay Blvd · Naples, FL · 34108-2755
Is this the product you have?
- Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only
- Manufactured forLupin Pharmaceuticals, Inc., Naples, FL 34108, United States
- Manufactured byLupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
- Lot codes and dates
Lot #: WB00006Exp 12/31/2026
- Amount recalled
- 32736 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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