Endo Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Dexmedetomidine HCL in 0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.
What happened
Par Health USA, LLC is voluntarily recalling two lots of Dexmedetomidine HCL in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4mcg/mL), Rx Only, 10x100 mL Single-Dose Vials per carton, due to the presence of particulate matter identified as cellulose or stopper material. The recall was announced by the company on September 18, 2026, and the company began the recall on September 21, 2026.
The product was added to the FDA's Enforcement Report on September 29, 2026, and was in the FDA's weekly enforcement report on October 7, 2026.
The recalled product was distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025. The product is manufactured for Endo USA, Malvern, PA 19355, and the recall is to the hospital level.
Summary by Recall Canary from the FDA notice.
What to do
If a code on your package matches:
- 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. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution.
- Questions regarding this recall can be directed to Inmar, Inc. at 1-833-599-3197 Monday through Friday between the hours of 9 a.m. and 5 p.m. ET or by email at rxrecalls@
inmar.com. - For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393 Monday through Thursday between the hours of 9 a.m. and 8 p.m. ET or Friday between 9 a.m. and 6 p.m. ET.
Is yours affected?
Affected if its NDC and lot code are listed under that product.
Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
- NDC
- 42023-187-10
- 42023-187-01
- Lot
- 87558
- 88802
Details
- Company began the recall
- Sold in
These lots were distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025.
- Event ID
- 99890
- Company
- Par Health USA, LLC
- Hazard
- Foreign material
- Quantity recalled
- 773 10x100ml vials per carton
Announced by the company
Company began the recall · Listed on Recall Canary
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Summary updated
