November 2025 FDA Recall Ganirelix Acetate by Lupin Pharmaceuticals Inc.
D-0220-2026 - Failed impurities/degradation specifications

This Class II drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on November 13, 2025 for the product Ganirelix Acetate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in FL, MA, MI & OH and the recall is currently ongoing.

Recall Number: D-0220-2026

Reason for Recall
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Initiated
11-13-2025
Reported
12-17-2025
Quantity
32736 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97990
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, MA, MI & OH
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : WB00006, Exp 12/31/2026

Affected Packages Involved in this Recall

70748-274-01 Ganirelix Acetate