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
Reported: December 17, 2025 Initiated: November 13, 2025 #D-0220-2026
Product Description
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 32736 vials
- Distribution
- FL, MA, MI & OH
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 32736 vials.
Why was this product recalled? ▼
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2025. Severity: Moderate. Recall number: D-0220-2026.
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