Par Health recalls two Brevital lots over cellulose contamination

Par Health is voluntarily recalling two lots of Brevital Sodium 500 mg/vial CIV to the hospital level because particulate matter identified as cellulose was found in the product, according to a notice posted by the FDA. The affected lots are 86930 and 88623. They were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026. Brevital is used for induction of anesthesia and procedural sedation.

The company said administration of product containing particulate matter has a reasonable probability of causing life-threatening consequences, including pulmonary emboli, blockages in other blood vessels, or inflammation of vein walls that may lead to clotting. Par Health said it has received no reports of adverse events related to the recall. The company is notifying wholesale accounts and arranging returns through Inmar. Distributors and hospital pharmacies with the recalled product should immediately discontinue use and stop distribution.