FDA Recall D-0220-2026

Lupin Pharmaceuticals Inc. · Naples, FL

Class II Ongoing 182 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: WB00006, Exp 12/31/2026

Quantity: 32736 vials

Reason for recall

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

Recall record

Recall number: D-0220-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: FL, MA, MI & OH
Recall initiated: 2025-11-13
Classified by FDA Center: 2025-12-08
FDA published: 2025-12-17
Recalling firm: Lupin Pharmaceuticals Inc.
Firm location: Naples, FL

Drug identification

Brand name(s): GANIRELIX ACETATE
Generic name(s): GANIRELIX ACETATE
Manufacturer(s): Lupin Pharmaceuticals, Inc.
NDC(s): 70748-274
Route(s): SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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