FDA recall, , Moderate risk
Meitheal Pharmaceuticals Cetrorelix Acetate for Injection (Kit)
Cetrorelix Acetate for Injection kits may have missing or duplicated needles.
Summary by Recall Canary from the FDA notice
What happened
Meitheal Pharmaceuticals, Inc. of Chicago, Illinois is recalling Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, due to a defective delivery system that may result in missing or duplicated needles within the injection kit. The recall affects 16,477 kits distributed nationwide in the U.S. and was initiated on February 9, 2026.
The product is manufactured for Meitheal Pharmaceuticals, Chicago, IL. The FDA added the recall to its Enforcement Report on February 11, 2026, and classified it on February 23, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 71288-558-90
- Lot code
- Q4E0112A
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- Meitheal Pharmaceuticals, IncChicago, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98386
- Recall number
- D-0340-2026
- Quantity recalled
- 16,477 kits
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
Summary updated
