Par Health Recalls Two Lots of Dexmedetomidine HCl Due to Particulate Matter

ROCHESTER, Mich., Sept. 18, 2026 /CourierPR/ -- Par Health, a pharmaceutical company, has issued a voluntary nationwide recall of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) due to the presence of particulate matter. The affected lots, identified as Lots 87558 and 88802, were distributed to wholesalers between May 13, 2025, and June 29, 2025.

The recall affects a specific formulation of the drug, which is intended for intravenous infusion in medical settings. The product is used for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting and for sedation of non-intubated adult patients prior to and during surgical and other procedures.

According to the press release, the particulate matter identified in the product is believed to be cellulose or stopper material. The presence of such particles poses a significant risk, with a reasonable probability of causing life-threatening adverse health consequences. These consequences include pulmonary emboli, occlusions of other blood vessels leading to tissue death and possible organ damage, and inflammation of the walls of veins, which may lead to clotting.

To date, Par Health has not received any reports of adverse events related to this recall. The company is providing written notification to wholesale accounts that have received the affected lots and is arranging for the return of all existing inventory of Lots 87558 and 88802 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution. If any of the recalled product has been further distributed, these entities are advised to notify their accounts or any additional locations that may have received the recalled product.

Par Health is conducting this recall with the knowledge and support of the U.S. Food and Drug Administration (FDA). The FDA's MedWatch Adverse Event Reporting program is available for individuals to report any adverse reactions or quality problems experienced with the use of this product. The program can be accessed online at www.fda.gov/medwatch/report.htm or by regular mail or fax using the forms available at www.fda.gov/MedWatch/getforms.htm or by calling 1-800-332-1088 to request a reporting form.