FDAFDA · Food and drugs·Recall number D-0220-2026
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
Published December 17, 2025 · Recall initiated: November 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- GANIRELIX ACETATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- FL, MA, MI & OH
- UPC
- 0370748274019
- Lot
- Lot #: WB00006, Exp 12/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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