Par Health recalls two lots of Brevital Sodium injection due to particulate matter

Par Health voluntarily recalls two lots of Brevital Sodium 500 mg/vial CIV, an anesthetic used for procedural sedation, due to cellulose particulate contamination. The affected lots, 86930 and 88623, were distributed nationwide between July 2025 and May 2026. While no adverse events are reported as of October 8, 2026, administering the contaminated drug poses life-threatening risks like pulmonary emboli. Par Health is coordinating returns through Inmar, Inc.

Details of the recall

• ▪On October 8, 2026, Par Health voluntarily recalled two lots of Brevital Sodium 500 mg/vial CIV to the hospital level.
• ▪Par Health initiated the recall of Brevital Sodium 500 mg/vial CIV due to the presence of particulate matter identified as cellulose.
• ▪The recalled Brevital Sodium lots, numbered 86930 and 88623, were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026.

Recall instructions and inquiries

• ▪Customers can direct questions regarding the Brevital Sodium recall to Inmar, Inc. at 1-844-774-1187 or via email at rxrecalls@inmar.com.
• ▪Par Health is notifying wholesale accounts and arranging for the return of all existing inventory of the affected lots through Inmar, Inc.
• ▪Par Health instructed wholesale distributors and hospital pharmacies to immediately discontinue use and stop distribution of the recalled Brevital Sodium lots.

Adverse Event Reporting and status

• ▪As of October 8, 2026, Par Health had received no reports of adverse events related to the recalled Brevital Sodium lots.
• ▪Adverse reactions or quality problems experienced with Brevital Sodium may be reported to the United States Food and Drug Administration's MedWatch program.

Risks of particulate contamination

• ▪Administering Brevital Sodium containing particulate matter carries a reasonable probability of causing life-threatening consequences, including pulmonary emboli and blood vessel occlusions.
• ▪Particulate matter in Brevital Sodium can cause inflammation of vein walls, potentially leading to blood clotting, tissue death, and organ damage.

About Brevital Sodium

• ▪Brevital Sodium 500 mg/vial CIV is formulated for intravenous infusion in adult patients or intramuscular induction in pediatric patients.
• ▪Brevital Sodium 500 mg/vial CIV is an ultra-short-acting barbiturate anesthetic indicated for anesthesia induction and procedural sedation.