Warning
Lupin Pharmaceuticals Inc. Recalls Ganirelix Acetate Injection
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0220-2026Drug / Pharmaceutical
Lupin Pharmaceuticals Inc. Recalls Ganirelix Acetate Injection
Lupin Pharmaceuticals Inc. · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
FL, MA, MI & OH
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Lupin Pharmaceuticals Inc. has recalled a pharmaceutical product that the FDA classified as Class II affecting 32736 vials. The recall was initiated on November 13, 2025. Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. It was distributed in FL, MA, MI & OH. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.