Lupin recalls Ganirelix Acetate Injection prefilled syringes over impurity levels that failed testing
Tests found an impurity, called the acrylic acid adduct, at levels outside the allowed limit in the injection, which means the medicine did not meet its quality standards.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall 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
- Company
- Lupin Pharmaceuticals Inc.
- Hazard
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Units
- 32736 vials
- Where sold
- FL, MA, MI & OH
- FDA classification
- Class II · Ongoing
- Classified by FDA
- December 8, 2025
- Recall started
- November 13, 2025
- FDA enforcement report
- December 17, 2025
- Identifiers
- Codes: Lot #: WB00006, Exp 12/31/2026
- FDA recall number: D-0220-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
- Classification
- Class II (Ongoing)
- Distribution
- FL, MA, MI & OH
- Quantity
- 32736 vials
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