Medications & Supplements/Prescription Drugs

Cetrorelix Acetate for Injection Recalled for Defective Delivery System

Agency Publication Date: February 11, 2026

Summary

Meitheal Pharmaceuticals, Inc. is recalling 16,477 units of Cetrorelix Acetate for Injection (0.25 mg per vial) kits due to a defective delivery system. Some injection kits may contain missing or duplicated needles, which can interfere with the proper administration of the medication. The recall affects single-dose kits from lot Q4E0112A with an expiration date of April 30, 2027.

Risk

Missing or duplicated needles within the injection kit may lead to delays in treatment or improper dosing if the user does not have the necessary components to administer the injection as prescribed.

What You Should Do

Check your injection kit for lot number Q4E0112A and an expiration date of 30 Apr 2027 printed on the packaging.
Inspect the kit to ensure all required needles are present and that there are no duplicate components before attempting use.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cetrorelix Acetate for Injection (Kit)

Variants: 0.25 mg per vial, Single-Dose Kit

Lot Numbers:

Q4E0112A (Exp: 30 Apr 2027)

NDC:

71288-558-90

Rx Only; Manufactured for Meitheal Pharmaceuticals

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98386

Status: Active

Manufacturer: Meitheal Pharmaceuticals, Inc

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 16,477 kits

Distributed To: Nationwide

Agency Last Updated: March 2, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your injection kit for lot number Q4E0112A and an expiration date of 30 Apr 2027 printed on the packaging.

Inspect the kit to ensure all required needles are present and that there are no duplicate components before attempting use.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.