FDA-PR2026-09-18PROCESSING DEFECT

Par Pharmaceutical dexmedetomidine injection recalled for particulate matter contamination

PLASTICNationwide distributionDrugsBaby & kids

What this means

Par Pharmaceutical is recalling two lots of dexmedetomidine HCl injection used in hospitals for patient sedation. The vials contain unwanted particles of cellulose or stopper material that could cause serious blood vessel blockages or clotting if injected into patients. No patient injuries have been reported so far.

  • If you work in a hospital pharmacy or ICU: immediately stop using lots 87558 and 88802 and remove them from shelves.
  • Contact your pharmaceutical supplier or Inmar at 1-833-599-3197 (Mon–Fri, 9 a.m.–5 p.m. ET) to arrange return of affected inventory.
  • Report any patient exposures or adverse events to FDA MedWatch at www.fda.gov/medwatch or 1-800-332-1088.

Product photos

Label, Dexmedetomidine HCl in 0.9% Sodium Chloride Injection with Lot 88802
Label, Dexmedetomidine HCl in 0.9% Sodium Chloride Injection with Lot 88802
Label, Dexmedetomidine HCl in 0.9% Sodium Chloride Injection with Lot 87558
Label, Dexmedetomidine HCl in 0.9% Sodium Chloride Injection with Lot 87558
The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported

Official notice

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-health-issues-voluntary-nationwide-recall-two-lots-dexmedetomidine-hcl-09-sodium-chloride

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