D-0220-2026 Class II Ongoing
FDA drug recall D-0220-2026 was initiated by Lupin Pharmaceuticals Inc. on Nov 13, 2025 and is designated Class II. Reason for recall: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. The recall status is ongoing. Affected quantity: 32736 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2025
- Initiation Date
- Nov 13, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32736 vials
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.
Distribution Pattern
FL, MA, MI & OH
Code Information
Lot #: WB00006, Exp 12/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0220-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026