United States
What's being recalled
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose.
Administration of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), found to contain particulate matter, has a reasonable probability of causing life-threatening 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.
Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) is formulated for intravenous infusion in adult patients or intramuscular induction in pediatric patients. The product is indicated as an ultra-short-acting barbiturate anesthetic primarily used for the induction of anesthesia and procedural sedation.
Recalled product can be identified as follows and by labels at bottom of this document:
Product: Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), Distributed by: Par Pharmaceutical*; Size: 42023-105-01; Item Code: 86930; Lot Numbers: 02/2028
Product: 88623; Size: 04/2028
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 86930 and 88623 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.
Questions regarding this recall can be directed to Inmar, Inc. at 1-844-774-1187 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Package Identification:
See examples of vial labels from the affected lots below:
Company Contact Information
Consumers:
Inmar, Inc.
1-844-774-1187
rxrecalls@inmar.com
Media:
Gena Holthaus, Senior Director, Corporate Brand and Communications
media.relations@parhealth.com
Product Photos
The hazard
Presence of particulate matter identified as cellulose
What to do
Contact: Consumers: Inmar, Inc. 1-844-774-1187 rxrecalls@inmar.com Media: Gena Holthaus, Senior Director, Corporate Brand and Communications media.relations@parhealth.com
Where it was sold
These lots were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration, collected from U.S. Food and Drug Administration. Check the original before you act on it.
Read the official notice (opens in a new tab)