Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection
- Recalling company
- Lupin Pharmaceuticals Inc.
- 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
- Reason
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 13, 2025
- Reported
- Dec 17, 2025
- Distribution
- FL, MA, MI & OH
- Status
- Ongoing
- Quantity
- 32736 vials
- Lot / codes
- Lot #: WB00006, Exp 12/31/2026
- Company location
- Naples, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0220-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0220-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.