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
- Date
- Sep 18, 2026
- Company
- Par Health
- Brand
- Par Pharmaceutical
- Product
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
- Reason
- Presence of particulate matter identified as cellulose or stopper material
- Hazard
- Other
- Source
- FDA
How to identify the product
- These lots were distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025.
- Par Health is providing written notification to wholesale accounts that have received the affected lots and are arranging for return of all existing inventory of Lots 87558 and 88802 through Inmar, Inc.
- If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.