Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ganirelix Acetate Injection Recalled by Lupin Pharmaceuticals Inc. Due to Failed impurities/degradation specifications: out of specification results for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Lupin Pharmaceuticals Inc. directly.
Affected Products
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
Quantity: 32736 vials
Why Was This Recalled?
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Where Was This Sold?
This product was distributed to 4 states: FL, MA, MI, OH
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report