Ganirelix Acetate Injection, Solution
FDA Recall NDC 70748-274
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ganirelix Acetate (NDC 70748-274). A significant event, classified as Class II, was initiated on Nov 13, 2025 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
November 2025 Class II Recall: Failed impurities/degradation specifications
Recall Number
Class II Ongoing
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Nov 13, 2025
Dec 17, 2025
32736 vials
Recall Profile & Regulatory Data
Event ID
97990
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, MA, MI & OH
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
Batch or Lot Expiration Information
Lot# : WB00006, Exp 12/31/2026
Affected Packages Involved in this Recall
70748-274-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
