FDA recall D-0220-2026

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.

Distribution

FL, MA, MI & OH

Key facts

Status

Ongoing

Initiation date

2025-11-13

Report date

2025-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0220-2026