Par Health has issued a voluntary recall of two lots of the IV sedative dexmedetomidine HCl in 0.9% sodium chloride injection that may be contaminated with cellulose or stopper material.
The recall is taking place on the hospital level for the pair of batches that were distributed across the country by wholesalers between May and June of 2025. The products were identified as lot numbers 87558 and 88802, carrying expiration dates of February 2027 and April 2027, respectively.
Par's dexmedetomidine product is administered by intravenous infusion for the sedation of adult patients either intubated and mechanically ventilated during treatment in an intensive care setting, the company said. It is also used to sedate patients before and during surgery and other medical procedures.
As of Sept. 18, the company said it had not received any reports of adverse events related to the recall.
Par Health warned that using the recalled product had a “reasonable probability” of causing life-threatening effects such as pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), or inflammation of the walls of veins, which may lead to clotting.
Wholesale, distributors and hospital pharmacies with the product should immediately discontinue use of the recalled lots and halt any distribution, the company said in its recall notice, which was posted to the FDA's website late last week.
Par is just one of many companies to grapple with recent particulate contamination concerns. In many instances of recalls from this past year, the issue has specifically impacted drug solutions typically infused in hospitals.