FDA Drug Recall Alert – Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
| Date: | September 30, 2026 |
| From: | Health Plan of San Joaquin/Mountain Valley Health Plan (“Health Plan”) |
| To: | Health Plan All Providers |
| Type: | Informational |
| Subject: | State of Emergency Declared Developing 2026–2027 El Niño Event |
| Business: | Medi-Cal Managed Care/Medicare Advantage D-SNP |
On September 21, 2026, the Food and Drug Administration (FDA) released a recall announcement on Dexmedetomidine HCl in 0.9% Sodium Chloride Injection.
This is for informational purposes only. You may or may not have administered the medication. Please disregard if you have not been affected by this recall.
For the complete details regarding this recall announcement, please visit the following web link: https://www.fda.gov/safety/recalls-market-withdrawalssafety-alerts/par-health-issues-voluntary-nationwide-recall-two-lotsdexmedetomidine-hcl-09-sodiumchloride?utm_medium=email&utm_source=govdelivery
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
Company Announcement
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 material. Administration of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL, found to contain particulate matter, has a reasonable probability of causing lifethreatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting. To date, Par Health has not received any reports of adverse events related to this recall.
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) is formulated for intravenous infusion. The product is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting and for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
Affected Products
These lots were distributed nationwide to wholesalers between May 13, 2025 and June 29, 2025.
| Product | NDC | Lot | Expiration Date |
|---|---|---|---|
| Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion, Distributed by: Par Pharmaceutical | 42023-187-01 | 87558 | 02/2027 |
| 88802 | 04/2027 |
What to Do
04/2027 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. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.
Contact Information
Consumers:
Inmar, Inc.
1-833-599-3197
rxrecalls@inmar.com
Media:
Gena Holthaus, Senior Director,
Corporate Brand and Communications
media.relations@parhealth.com
If you have any further questions, please contact your Provider Services Representative, or call our Customer Service Department at 1-888-936-PLAN (7526). You may also visit https://www.hpsj.com/alerts/ for online access to the documents shared. The most recent information about Health Plan and our services is always available on our website www.hpsj-mvhp.org
