On February 9, 2026, Meitheal Pharmaceuticals, Inc initiated a Class II recall of Cetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit. The product is distributed under NDC 71288-558-90 and is Rx Only.
The recall reason cited is a defective delivery system, specifically missing or duplicated needles within the injection kit. The FDA classified this recall as Class II. The recall status is listed as ongoing.
This action was initiated by the manufacturer as a facts-based recall event tied to kit component defects. The recall does not, by itself, indicate that cetrorelix acetate as a compound is unsafe. It reflects an issue with the physical delivery kit contents rather than the drug substance itself.
Cetrorelix remains an approved compound. This recall is limited to the specific lot or lots affected by the delivery system defect described above.
For more background on this compound, readers can consult the compound overview.