Brevital Recall Reaches an OR and ECT Anesthesia Drug

Brevital Sodium (methohexital)What to know

30-second read

For Anesthesiology · Psychiatry

Who

Hospitals and ECT suites holding Lot 86930 (exp. 02/2028) or Lot 88623 (exp. 04/2028) of Brevital Sodium, NDC 42023-105-01.

What happened

Par Health recalled both lots to the hospital level on 9 October 2026 after cellulose particulate turned up in vials of this IV induction agent.

Immediate concern

Par Health warns of a “reasonable probability” of life-threatening harm — pulmonary emboli, vessel blockage — if particulate is injected.

What to check

Quarantine remaining stock of both lots in OR, pre-op and ECT-suite trays now; do not wait for a formal recall classification to act.

Recall status

No Class I/II/III classification assigned as of 10 October; no adverse events reported to date. Second particulate recall from Par Health in three weeks.

Alternatives

Propofol, etomidate and ketamine remain available for induction; for ECT they affect seizure duration differently — see the comparison below.

Practice impactAct now

Quarantine affected lots this week. Anesthesia and ECT teams should confirm their backup induction agent and know its seizure-duration tradeoffs before the next case, not during it.

Read the full physician analysis

Full analysis · 7 min readFDA recall notice, 9 Oct 2026 · FDA warning letter, 15 Apr 2026 · ECT-anesthesia literature

Par Health is recalling two lots of Brevital Sodium (methohexital sodium for injection, USP), an ultra-short-acting barbiturate used to induce general anesthesia and — in psychiatry — to induce seizures for electroconvulsive therapy (ECT). FDA posted the recall on 9 October 2026 after cellulose particulate was found in vials; Par Health warns of a “reasonable probability” of life-threatening harm, including pulmonary emboli, if the particulate reaches a patient intravenously. It is the company's second sterile-injectables recall for a particulate contaminant in three weeks.

What is recalled, and how far it travelled

The recall covers Lot 86930 (expires February 2028) and Lot 88623 (expires April 2028) of Brevital Sodium 500 mg/vial CIV, NDC 42023-105-01. Par Health distributed both lots nationwide to wholesalers between 8 July 2025 and 11 May 2026, and the recall reaches the hospital level — meaning affected vials may already be sitting in OR anesthesia carts, pre-op supply rooms or ECT-suite medication trays rather than stopped at a distribution warehouse. The company is notifying wholesale accounts in writing and coordinating returns through Inmar, Inc. As of this report, FDA has not posted a Class I, II or III classification; that determination typically follows a recall's initiation by several weeks and should not be waited on before quarantining stock.

Why cellulose in an IV vial matters

Brevital is given intravenously, which puts any particulate on a direct path to the bloodstream and, from there, the lungs. Par Health's notice identifies the contaminant as cellulose and states a reasonable probability that administering product containing it could cause serious, potentially life-threatening consequences — pulmonary emboli, vessel blockage, vein inflammation or clotting — if the particles are injected and travel to the lungs. No adverse events had been reported to Par Health as of the recall notice. The practical instruction for a hospital or ECT program holding either lot is the same regardless of classification: pull the product from circulation now and follow the manufacturer's return instructions.

A second cellulose recall, and a prior warning letter

This is not an isolated event. Around 18 September 2026, Par Health recalled two lots of dexmedetomidine HCl in 0.9% sodium chloride injection — a separate IV sedative — after cellulose or stopper material was found in the product, using nearly identical risk language. And in April 2026, FDA issued a CGMP warning letter to Par Health USA, LLC and Endo USA, Inc. citing aseptic-processing deficiencies, including restricted-access barrier system (RABS) lines that did not meet RABS criteria, at the company's Rochester, Michigan sterile-injectables facility. Neither recall notice draws an explicit line to the warning letter or to each other, and nothing public confirms a single root cause connects all three. But for a hospital pharmacy or quality team tracking one manufacturer's sterile-injectables output, two particulate recalls in a month from a company under an open aseptic-processing warning letter is a pattern worth tracking, not three isolated events.

Methohexital's place in the OR and the ECT suite

Methohexital's clinical role splits two ways. In the operating room, it is one of several agents used to induce general anesthesia or supplement other agents, dosed as a rapid IV bolus with a short duration of action. In psychiatry, it has long been one of the standard agents for inducing anesthesia before ECT, chosen because of how it behaves relative to the alternatives on the two things an ECT team actually watches: seizure threshold and seizure duration. Comparative studies consistently show propofol shortens motor seizure duration relative to methohexital without raising seizure threshold, while etomidate tends to produce longer seizures than propofol with a similar discharge profile. Neither of those studies changes methohexital's own pharmacology; they describe why some programs have kept it as a default and others have moved away from it for reasons of recovery time or hemodynamic stability rather than seizure quality.

Induction agents if methohexital supply is constrained

	Methohexital	Propofol	Etomidate	Ketamine
Effect on ECT seizure duration	Reference agent in most comparative trials	Shortens motor seizure duration vs. methohexital	Tends to produce longer seizures than propofol	Generally favorable seizure characteristics
Hemodynamics	Generally stable	Can cause hypotension	Comparatively stable	Raises heart rate and blood pressure
Notable tradeoff	This recall; a Schedule IV controlled substance	Fastest recovery, but the seizure-shortening effect above	More postictal agitation/myoclonus reported	Possible added antidepressant effect; opposite hemodynamic profile from propofol

Seizure-duration and hemodynamic comparisons from published ECT-anesthesia literature (see references). Not a substitute for an institution's own anesthesia and ECT protocols; do not switch an established agent without anesthesia and psychiatry input.

No current FDA or ASHP drug-shortage listing for methohexital was confirmed at the time of this report, and this recall affects two specific lots rather than the national supply. The comparison above is for programs that hold affected stock and need a documented alternative while they work through the recall — not a signal that methohexital itself should be abandoned.

What changes at the bedside and in the ECT suite

• Quarantine now. Check anesthesia carts, pre-op supply and ECT medication trays for Lot 86930 or 88623; do not wait for an FDA classification to pull stock.
• Document the switch. If methohexital becomes unavailable, record which alternative agent an ECT patient receives and watch for a change in seizure adequacy at the next treatment, since propofol and methohexital are not interchangeable at the same dose or with the same seizure-duration profile.
• Loop in anesthesia and psychiatry together. An ECT program's induction agent is usually set by protocol; a supply-driven switch should go through the same multidisciplinary sign-off as any other protocol change, not an ad hoc pharmacy substitution.
• Watch the pattern, not just the lot numbers. This is Par Health's second particulate recall in three weeks, from a facility under an open FDA warning letter. A quality or pharmacy team sourcing other sterile injectables from Par Health has reason to ask the distributor about additional lots.

Nothing in this recall changes what methohexital is or how it works. What it changes, for any hospital or ECT program holding the two named lots, is supply — and the task this week is the ordinary one of any sterile-injectable recall: find the product, quarantine it, and have a documented backup ready before the next case.

Frequently asked questions

Which lots of Brevital Sodium are recalled?

Lot 86930 (expires February 2028) and Lot 88623 (expires April 2028) of Brevital Sodium 500 mg/vial CIV (methohexital sodium for injection, USP), NDC 42023-105-01, distributed nationwide to wholesalers between 8 July 2025 and 11 May 2026. Par Health's recall reaches the hospital level.

Is methohexital still a preferred agent for ECT?

It has long been one of the standard induction agents for ECT because, compared with propofol, it raises seizure threshold and shortens seizure duration less — a property some clinicians weight when seizure adequacy is a concern. That said, programs vary, and some have moved to propofol or etomidate for other reasons (recovery profile, hemodynamic stability). This recall does not change methohexital's pharmacology; it is a supply and contamination issue for two specific lots.

Has FDA classified this as a Class I, II or III recall?

Not as of 10 October 2026. FDA typically assigns a classification in the weeks after a recall is initiated; Par Health's own notice had posted the day before, on 9 October. Regulatory News will update this story when a classification appears in FDA's enforcement reports.