FDAHealthNovember 13, 2025
Lupin Pharmaceuticals Inc. — 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,
⚠️ Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Is this relevant to me?
- Geography
- FL, MA, MI, OH
- Source agency
- FDA
- Category
- Health
- Published
- November 13, 2025
FL, MA, MI & OH
What's affected?
- 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
- Brand
- GANIRELIX ACETATE
- UPC
- 0370748274019
- Lot code
- WB00006
Additional details
Lot #: WB00006, Exp 12/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 32736 vials.
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