Key Takeaway

Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vi by Meitheal Pharmaceuticals Inc was recalled on February 9, 2026. The hazard: Defective Delivery System: Missing or duplicated needles within the injection kit

FDA Drug Class II Ongoing

Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vi

Recalled: February 9, 2026 ~16,477 kits units affected D-0340-2026

Description

Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vial, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631, Made in China, NDC: 71288-556-02. Syringe: Sterile Water for Injection, USP, 1 mL, Meitheal Pharmaceuticals, Chicago, IL 60631, Made in China, NDC: 71288-557-81

Hazard / Reason

Defective Delivery System: Missing or duplicated needles within the injection kit

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vi

Drugs

Company Information

Meitheal Pharmaceuticals Inc

Chicago, IL, United States

View all 3 recalls by Meitheal Pharmaceuticals Inc →

Distribution

U.S. Nationwide

Related Recalls

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

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