Par Health Recalls Two Dexmedetomidine Lots Over Particulate Risk
Rochester, Mich. – September 20, 2026 -- Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) at the hospital level after detecting particulate matter identified as cellulose or stopper material.
Contaminated vials carry risk of pulmonary emboli and vessel occlusion
The FDA-notified recall covers Lots 87558 and 88802, which were distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025. Par Health warned that administering the affected product carries a reasonable probability of causing life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels that can lead to tissue death and organ damage, and inflammation of vein walls that may result in clotting. The company said it has not received any adverse event reports tied to the recall to date.