Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial
Recalled by Meitheal Pharmaceuticals, Inc
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Meitheal Pharmaceuticals, Inc has recalled Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on February 18, 2026 and was initiated on February 9, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, with approximately 16,477 kits affected. The company behind the recall is Meitheal Pharmaceuticals, Inc, based in Chicago, IL. The FDA describes the product as: “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.”
Why was Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial recalled?
According to the FDA, the stated reason for the recall is: “Defective Delivery System: Missing or duplicated needles within the injection kit.”
What should you do?
If you think you may have bought Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, compare it against the product description and identifying codes (Lot Q4E0112A, Exp.: 30 Apr 2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Meitheal Pharmaceuticals, Inc or your local health authority.
About this recall
This recall was distributed in IL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- February 18, 2026
- Recall started
- February 9, 2026
- Distributed in
- IL
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial recalled?+
According to the FDA: Defective Delivery System: Missing or duplicated needles within the injection kit
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0340-2026. Information last synced from the FDA on July 5, 2026.