Two lots of dexmedetomidine, a sedative widely used for patients on ventilators in intensive care units, are being pulled from hospitals nationwide after particles identified as cellulose or stopper material were found in the product. Par Health announced the recall on Sept. 18, and the FDA has posted the company's notice.
The lots were shipped to wholesalers between May 13 and June 29, 2025, and do not expire until early 2027. That means affected vials may have been sitting in hospital pharmacies for more than a year before the recall was announced.
For families with a loved one in intensive care or scheduled for a sedated procedure, the practical question is whether hospitals have found and removed the product. Par Health says it has received no reports of adverse events.
According to the FDA-posted recall notice, giving the affected product carries a "reasonable probability of causing life-threatening adverse health consequences."
Two Lots, More Than a Year in Circulation
The recall covers Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4 mcg/mL), NDC 42023-187-01, distributed by Par Pharmaceutical. The affected lots are 87558, which expires in February 2027, and 88802, which expires in April 2027.
The recall extends to the hospital level. Par Health is notifying wholesale accounts in writing and arranging returns through Inmar, Inc. Wholesalers and hospital pharmacies that have the lots are told to stop using and distributing them immediately, and anyone who further distributed the product is asked to notify those locations.
The notice leaves several gaps. It does not say how the particles were detected, how many vials are affected, whether any affected vials were given to patients, or where the material came from. No FDA recall classification had been announced when this report was published.
The long gap between shipment and recall matters for hospitals. Product that shipped in spring 2025 could already have been used, and pharmacies may need to check satellite and automated cabinet stock, not only central inventory.
Dexmedetomidine is approved for sedating adults who are intubated and on mechanical ventilation in intensive care, and for sedating adults who are not intubated before or during surgery and other procedures. That places it in ICUs, operating rooms, and procedure suites across the country. Because it is one of the standard options for sedating ventilated ICU patients, any disruption matters beyond inventory.
Particles in an IV Line Carry Specific Risks
Particles injected directly into a vein can travel to the lungs and other organs. The notice lists pulmonary emboli, which are blockages in lung blood vessels, along with blockages in other vessels that can cause tissue death and organ damage, and inflammation of vein walls that may lead to clotting.
Those are potential consequences, not events anyone has reported. That distinction is the central limit on what this recall can tell the public. Patients in intensive care are already seriously ill, however, which may make a new lung or clotting problem harder to recognize quickly.
MedicalDaily has reported on a run of particulate recalls involving hospital IV fluids this summer, including saline lots from Baxter and B. Braun. Those actions involved different products and manufacturers and have not been linked to this one.
A Recall Landing on a Strained Supply
The recall follows a summer in which dexmedetomidine appeared on federal shortage tracking. In July, Becker's Hospital Review reported, citing the FDA shortage database, that several manufacturers, including Fresenius Kabi and Par Health, had dexmedetomidine presentations on backorder because of shipping delays and increased demand. MedicalDaily could not independently confirm the current availability of every presentation as of Sept. 22.
The drug has also drawn attention outside the ICU. MedicalDaily reported on a Philadelphia case series in which 73.7% of 209 patients hospitalized with opioid withdrawal complicated by suspected medetomidine exposure received dexmedetomidine infusions. That study did not examine supply, and it does not show that such cases contributed to backorders.
Pulling two lots may be absorbed easily if other supply is healthy, or it may push some hospitals toward other sedatives. Par Health's notice does not address supply, and families whose loved one's care team switches medications can ask how the substitute differs.
Families With a Loved One in Intensive Care
Patients and families cannot check vial lot numbers, and no one should refuse sedation or delay a needed procedure because of this notice. The responsibility sits with hospital pharmacies, which can match their inventory against the two lot numbers.
Families can ask the care team whether the hospital has reviewed its stock for the recalled lots. For patients who are awake after sedation, sudden shortness of breath, chest pain, or new pain, redness, swelling, or hardness along an IV site should be reported to a nurse right away. Those signs warrant evaluation regardless of any recall. Families who are unsure which medications a loved one received can ask the care team for a medication list, a reasonable request during any ICU stay.
Questions about the recall can go to Inmar at 1-833-599-3197, Monday through Friday from 9 a.m. to 5 p.m. Eastern, or by email at [email protected]. Adverse reactions can be reported to Par Health at 1-800-828-9393 or to the FDA's MedWatch program.
The next developments to watch are the FDA's recall classification, any company update on the source of the particles, and any change in dexmedetomidine supply. MedicalDaily will update this report if adverse events are reported or the recall expands.
Key Questions Answered
What is being recalled?
Par Health is recalling two lots, 87558 and 88802, of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL, NDC 42023-187-01.
Why was it recalled?
The product contains particulate matter identified as cellulose or stopper material.
What are the potential risks?
The notice lists possible blockages in lung blood vessels, blockages in other vessels that can damage tissue and organs, and vein inflammation that may lead to clotting.
Has anyone been harmed?
Par Health says it has received no reports of adverse events related to the recall.
Who uses this drug?
It is used to sedate adults on ventilators in intensive care and adults undergoing surgery or other procedures without a breathing tube.
Do patients need to do anything?
This is a hospital-level recall, so patients cannot check lot numbers themselves. Families can ask whether the hospital has reviewed its stock, and anyone with sudden breathing trouble, chest pain, or problems at an IV site should tell a nurse right away.
