FDA Media Alert Detail

FDA Safety Alert

Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

  • U.S. Food and Drug Administration
  • September 21, 2026
  • ID: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-two-lots-dexmedetomidine-hcl-09-sodium-chloride

FDA MedWatch Safety Alert

ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper materia

Content syndicated from the official FDA MedWatch Safety Alerts and Adverse Event Reporting Program.