FDA·Medicines·February 18, 2026

Meitheal recalls Cetrorelix Acetate for Injection kits over missing or doubled needles

Some Cetrorelix Acetate for Injection single-dose kits (0.25 mg per vial) may have a needle missing or two needles inside, so the injection may not be given as intended.

What to do

The notice does not give instructions. Read the official notice for details.

Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.

Recall details

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.
Hazard
Defective Delivery System: Missing or duplicated needles within the injection kit
Units
16,477 kits
Where sold
U.S. Nationwide
FDA classification
Class II · Ongoing
Classified by FDA
February 23, 2026
Recall started
February 9, 2026
FDA enforcement report
February 18, 2026
Identifiers
  • Codes: Lot Q4E0112A, Exp.: 30 Apr 2027
  • FDA recall number: D-0340-2026

The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.

Official notice

The notice's own wording from FDA.

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.
Reason for recall
Defective Delivery System: Missing or duplicated needles within the injection kit
Classification
Class II (Ongoing)
Distribution
U.S. Nationwide
Quantity
16,477 kits

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