FDA-Drug2026-10-21Class IPACKAGING DEFECT
Par Health Dexmedetomidine HCl injection recalled for particulate matter contamination
What this means
Par Health USA's Dexmedetomidine HCl injection vials contain unwanted particulate matter, identified as cellulose or stopper material. The contamination affects two specific lots distributed nationwide. This is a prescription medication used during anesthesia and sedation.
- Check your pharmacy or hospital records if you received this medication between the affected lot dates (Lot 87558 with expiration 02/28/2027 or Lot 88802 with expiration 04/30/2027).
- Do not use vials from these lots. Contact your healthcare provider or pharmacist immediately if you have questions.
- Report any adverse events to the FDA MedWatch program.
The agency's original wording
Hazard
Presence of Particulate Matter: the particulate was identified as cellulose or stopper material
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the U.S.A
Affected count
773 10x100ml vials per carton
Manufactured in
870 Parkdale Rd, Rochester, Michigan, United States
Products
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4mcg/mL), Rx Only, 10x100 mL Single-Dose Vials per carton, Manufactured for: Endo USA, Malvern, PA 19355, Carton: NDC 42023-187-10. Vial NDC: 42023-187-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0072-2027More Paragon 28 recalls
- FDA-Drug2026-10-07Buprenorphine Hydrochloride injection recalled for crystallization
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