February 2026 FDA Recall Cetrorelix Acetate by Meitheal Pharmaceuticals, Inc
D-0340-2026 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Meitheal Pharmaceuticals, Inc on February 9, 2026 for the product Cetrorelix Acetate. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0340-2026
Defective Delivery System: Missing or duplicated needles within the injection kit
02-09-2026
02-18-2026
16,477 kits
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Meitheal Pharmaceuticals, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
