Home / Recalls / Lupin Pharmaceuticals Inc. / D-0220-2026

D-0220-2026 Class II Ongoing

Recalled by Lupin Pharmaceuticals Inc. — Naples, FL

Recall Details

Product Type
Drugs
Report Date
December 17, 2025
Initiation Date
November 13, 2025
Termination Date
N/A
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

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