Cetrorelix Acetate Kit
FDA Recall NDC 71288-558
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 Cetrorelix Acetate (NDC 71288-558). A significant event, classified as Class II, was initiated on Feb 09, 2026 by Meitheal Pharmaceuticals Inc.. The reported reason for this action was: "Defective Delivery System: Missing or duplicated needles within the injection kit"
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
Class II Ongoing
Defective Delivery System: Missing or duplicated needles within the injection kit
Feb 09, 2026
Feb 18, 2026
16,477 kits
Recall Profile & Regulatory Data
Event ID
98386
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Meitheal Pharmaceuticals, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.
Batch or Lot Expiration Information
Lot# Lot Q4E0112A, Exp.: 30 Apr 2027
Affected Packages Involved in this Recall
71288-558-90Product
71288-556-02Product
71288-557-81Product
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.
