FDA Drugs recall ·
Ganirelix Acetate Injection, 250 mcg/0.5mL… recall
- Recall number
- D-0220-2026
- Date
- (initiated November 13, 2025)
- Company / brand
- Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd, Naples, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32736 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: WB00006, Exp 12/31/2026
Distribution
FL, MA, MI & OH
States: Florida Massachusetts Michigan
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0220-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.