Par Health Recalls Two Lots of ICU Sedative Dexmedetomidine Over Particulate Matter
核心洞察
Par Health (搜索) is voluntarily recalling two lots of dexmedetomidine HCl (搜索) in 0.9% sodium chloride injection to the hospital level after cellulose or stopper material was found.
The affected lots, 87558 and 88802, were distributed nationwide to wholesalers between May 13 and June 29, 2025, and expire in 2027.
Par Health (搜索) says particulate matter in the intravenous sedative carries a reasonable probability of life-threatening harm, including pulmonary emboli (搜索) and vessel occlusion.
Par Health (搜索) is voluntarily recalling two lots of Dexmedetomidine HCl (搜索) in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level after particulate matter identified as cellulose or stopper material was found in the product. The recall notice, dated September 18, was posted by the FDA on September 21 and is being conducted with the agency's knowledge.
The product is formulated for intravenous infusion and is indicated for sedation of initially intubated and mechanically ventilated adult patients during intensive care treatment, and for sedation of non-intubated adult patients before or during surgical and other procedures.
Identified Lots and Distribution
The recall covers lots 87558, which expires in February 2027, and 88802, which expires in April 2027. Both were distributed nationwide to wholesalers between May 13 and June 29, 2025, under NDC 42023-187-01, distributed by Par Pharmaceutical. Because distribution occurred more than a year ago, some product may already have been used. Par Health (搜索) has not said how many units are involved.
The recall is at the hospital level rather than the consumer level, so patients have no packages to check at home. Par Health (搜索) is providing written notification to wholesale accounts that received the affected lots and is arranging returns of all existing inventory through Inmar, Inc. (搜索) Wholesale distributors and hospital pharmacies holding the product should immediately discontinue use and stop distribution, and accounts that further distributed it are asked to notify their own customers.
Stated Risks of Particulate Contamination
Par Health (搜索) said administration of the affected product has a reasonable probability of causing life-threatening adverse health consequences. The company outlined three main dangers: particles lodging in the blood vessels of the lungs, a problem known as pulmonary embolism (搜索); occlusion 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.
Those are potential outcomes rather than reported harms. Stopper material comes from the rubber closure that seals a container, while cellulose is a plant-based fiber. Par Health (搜索) has not said how the particles entered the product or whether other lots were tested, and it has not published root-cause findings. The recall notice does not assign an FDA risk class; that classification usually appears later in the agency's weekly Enforcement Reports.
To date, Par Health (搜索) has not received any reports of adverse events related to the recall.
Supply Pressure on a Widely Used Sedative
The recall affects a drug that has struggled with supply. In July, Becker's Hospital Review reported that dexmedetomidine injection appeared in the FDA's shortage database, with several makers, including Fresenius Kabi and Par Health (搜索), listing presentations on backorder because of shipping delays and higher demand. The American Society of Health-System Pharmacists counted 227 active U.S. drug shortages in the second quarter of 2026.
Pulling two lots may add pressure on hospital pharmacies, particularly smaller hospitals with fewer backup suppliers. Hospitals generally have other sedatives available, and the choice of drug belongs to the care team. This is not the first quality problem for this medicine: in 2020, Fresenius Kabi recalled dexmedetomidine lots over possible trace lidocaine contamination, Fierce Pharma reported.
Reporting and Clinical Guidance
Questions about the recall can be directed to Inmar, Inc. (搜索) at 1-833-599-3197 Monday through Friday between 9 a.m. and 5 p.m. ET. Medical or technical product information, product complaints and adverse events can be reported to Par Health (搜索) at 1-800-828-9393 Monday through Thursday between 9 a.m. and 8 p.m. ET or Friday between 9 a.m. and 6 p.m. ET. Adverse reactions or quality problems may also be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.
The recall is limited to two specific lots from one manufacturer, and other dexmedetomidine products are not included. The notice does not call for contacting individual patients, and adults sedated in an ICU or during a procedure in recent months cannot tell which lot they received. People recently discharged after a hospital stay or procedure should watch for sudden shortness of breath, chest pain, or new swelling, redness or pain along the arm where an IV was placed. Those symptoms can have many causes but warrant prompt medical attention, and trouble breathing requires emergency care.
The FDA is expected to classify the recall, and shortage listings may shift as manufacturers update supply.