Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level due to the presence of particulate matter identified as cellulose or stopper material, the US Food and Drug Administration said.
The recall covers the nationwide market, according to the FDA notice dated September 18, 2026, which lists Rochester, Michigan, as the company's location.
Administration of the product found to contain particulate matter has a reasonable probability of causing life-threatening adverse health consequences, the FDA said. These include pulmonary emboli, or blockage in pulmonary blood vessels, occlusions of other blood vessels which can lead to tissue death and possible organ damage, and inflammation of the walls of veins, which may lead to clotting.
To date, Par Health has not received any reports of adverse events related to this recall.