FDAClass IIRecall started February 9, 2026

Cetrorelix Acetate for Injection 0.25 mg Recall

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.

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Cetrorelix Acetate for Injection 0.25 mg recalled?

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

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

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.

Which lot codes, UPCs or models are affected?

Lot Q4E0112A, Exp.: 30 Apr 2027

Agency record number
D-0340-2026
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.
Recalling firm
Meitheal Pharmaceuticals, Inc
Quantity
16,477 kits
Distribution
U.S. Nationwide
Recall started
February 9, 2026
Report date
February 18, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls