Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter

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:

Brevital® Sodium 500 mg/vial CIV 
(Methohexital Sodium for Injection, USP), 
Distributed by: Par Pharmaceutical*

These lots were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026.

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.