Lots 86930 and 88623 of Brevital Sodium, a 500 mg vial of methohexital sodium for injection, are being pulled from hospitals nationwide after Par Health found particulate matter that it identified as cellulose. The company announced the voluntary recall on Oct. 8, 2026, and the Food and Drug Administration posted it the next day, Oct. 9.
Par Health, of Rochester, Michigan, says it has received no reports of adverse events tied to the recall so far. The recall is conducted to the hospital level, and the company’s instructions are addressed to wholesalers and hospital pharmacies.
Lots 86930 and 88623
The two lots named in the FDA posting are 86930 and 88623. The posting lists expiration dates of February 2028 and April 2028 for the pair, and the product’s National Drug Code is 42023-105-01. Both lots were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026, a window of about ten months, so vials from either lot have had up to ten months to reach hospital pharmacies.
The drug is labeled Brevital Sodium 500 mg/vial CIV, and the “CIV” denotes a Schedule IV controlled substance. The new drug application behind it, NDA 011559 in the Drugs@FDA database, lists PH Health as the company.
Cellulose particles in an injectable
The stated reason is a single finding: “particulate matter identified as cellulose.” The posting gives no tally of how many vials held particles, where in the manufacturing or packaging chain the cellulose entered, or how Par Health detected it. It also gives no vial count per lot, so the number of vials in hospital hands cannot be read from the public notice.
Particles in an injected drug go straight into the bloodstream, which is why they draw recalls even without a confirmed injury. Par Health’s announcement says that administering the product “has a reasonable probability of causing life-threatening adverse health consequences.” It names three specific possibilities: pulmonary emboli, which are blockages in the lung’s blood vessels; blockages in other blood vessels that can lead to tissue death; and inflammation of the vein wall that may lead to clotting.
That language is the company’s own, and it echoes the FDA’s definition of its most serious recall class in its recalls background and definitions: a reasonable probability that use of a violative product can lead to serious adverse health consequences or death. The agency has not posted a class for the Brevital lots in the entry reviewed. The posting carries no quote from a named spokesperson; the media contact is Gena Holthaus, Senior Director, Corporate Brand and Communications at Par Health.
Methohexital as a hospital anesthetic
The drug label describes methohexital sodium as a rapid, ultrashort-acting barbiturate anesthetic. According to the prescribing information, adults receive it intravenously to induce anesthesia ahead of other general anesthetics, as a supplement to weaker inhaled agents, for short surgical, diagnostic or therapeutic procedures, and to induce a hypnotic state. Patients older than one month can receive it by intramuscular or rectal routes.
A boxed warning on the label limits the drug to hospital or ambulatory care settings that provide continuous monitoring, with resuscitation drugs and trained staff immediately available. That setting is why the recall runs through hospital channels. Each 500 mg vial is a freeze-dried powder that staff dissolve before use, and the label calls for sterile water for intermittent intravenous, rectal and intramuscular doses. The posting does not say whether the cellulose was found in the dry powder or in a reconstituted solution, a distinction that decides how a particle would reach the bloodstream.
The recall date structure is simple to follow: Par Health announced it on Oct. 8, the FDA published it on Oct. 9, and both lots carry a 2028 expiration, so none of the affected vials is near the end of its shelf life. Hospitals checking inventory therefore cannot rely on expiry dates to screen out the recalled vials; the lot number printed on the carton and vial is the identifier that matters.
Returns through Inmar and reporting problems
Wholesalers and hospital pharmacies holding either lot are told to stop using and distributing it. Par Health has arranged returns through Inmar, Inc., which can be reached at 1-844-774-1187 from 9 a.m. to 5 p.m. Eastern, Monday through Friday, or at [email protected]. Any recipient that passed the product on to its own customers is asked to notify those accounts. Questions about the product, complaints and adverse events go to Par Health at 1-800-828-9393, open Monday through Thursday from 9 a.m. to 8 p.m. Eastern and Friday from 9 a.m. to 6 p.m. Clinicians can also report a reaction or a quality problem through the FDA’s MedWatch program, online, by mail or by fax at 1-800-FDA-0178.
The agency keeps the full run of announcements on its drug recalls page. The Brevital notice is not marked as terminated, so Par Health’s recall remains open as of the posting date, and the FDA record contains no update to the two lots named in the Oct. 9 entry.
This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.
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