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.
Sedation drug is used in ICU and surgical settings nationwide
The intravenous infusion is indicated for sedating intubated and mechanically ventilated adult patients in intensive care, as well as non-intubated adult patients before or during surgical and other procedures. Its use in critical-care and perioperative settings raises the stakes for hospital pharmacies managing inventory continuity during the recall.
Par Health directs wholesale returns through Inmar as FDA oversees action
Par Health is sending written notice to wholesale accounts that received the affected lots and coordinating returns of all existing inventory through Inmar, Inc. Wholesale distributors and hospital pharmacies holding the recalled lots have been instructed to immediately discontinue use and stop further distribution, and to notify any downstream accounts that may have received the product. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.