Par Health has issued a voluntary nationwide recall of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection after particulate matter was found in the product.
The recall covers Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 micrograms/100 mL, or 4 micrograms/mL, for intravenous infusion. Par said the particles were identified as cellulose or stopper material. The company is recalling the products to the hospital level.
The affected lots are 87558, with an expiration date of February 2027, and 88802, with an expiration date of April 2027. Both products carry National Drug Code 42023-187-01 and were distributed by Par Pharmaceutical. The lots were shipped nationwide to wholesalers between May 13, 2025, and June 29, 2025.
Par said intravenous administration of the affected product could cause life-threatening adverse health consequences. Potential risks include pulmonary emboli, blockages of other blood vessels that could lead to tissue death or organ damage, and inflammation of vein walls that may result in clotting.
The company said it had not received reports of adverse events associated with the recall as of its Sept. 18 announcement.
Dexmedetomidine is used for sedation of initially intubated and mechanically ventilated adult patients in intensive-care settings. It is also indicated for sedation of non-intubated adults before and during surgical and other procedures.
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