Par Health recalled Brevital anesthesia lots over cellulose — second recall in three weeks

On October 9, 2026, Par Health — the Hazelwood, Missouri sterile-injectables maker formed from Mallinckrodt's and Endo's combined businesses — recalled two lots of Brevital Sodium (methohexital), a barbiturate used to induce general anesthesia and, in psychiatry, seizures for electroconvulsive therapy. Lots 86930 and 88623 of the 500 mg vials (NDC 42023-105-01) went out nationwide to wholesalers between July 8, 2025 and May 11, 2026, and the recall reaches hospital level: affected vials may be sitting in OR anesthesia carts, pre-op rooms and ECT medication trays.

The contaminant is cellulose particulate. Par Health warns of a 'reasonable probability' that injecting product containing it could cause serious, potentially life-threatening consequences — pulmonary emboli, vessel blockage, vein inflammation or clotting — because an IV dose puts particles on a direct path to the bloodstream and lungs. No adverse events had been reported to the company as of the recall notice, and FDA had not yet assigned a Class I, II or III classification.

The recall is not an isolated event. Around September 18, 2026, the company recalled two lots of dexmedetomidine, a separate IV sedative, after cellulose or stopper material was found, using nearly identical risk language. In April 2026, FDA issued a CGMP warning letter to Par Health USA and Endo USA citing aseptic-processing deficiencies — including RABS lines that did not meet RABS criteria — at the Rochester, Michigan facility. Neither recall notice draws an explicit line to the warning letter, but two particulate recalls in a month under an open letter is a pattern, not a coincidence.

Two lots (86930, 88623) recalled to hospital level nationwide; 'reasonable probability' of pulmonary emboli; no adverse events reported; FDA classification pending.

FDA had already cited aseptic-processing deficiencies at the Rochester, Michigan facility in an April 2026 warning letter, including RABS lines that failed RABS criteria.

A second particulate recall in three weeks, with near-identical risk language, points to a shared manufacturing weakness rather than two accidents.

Particulate in an intravenously injected drug bypasses every defensive layer between vial and bloodstream.

Nationwide wholesale distribution over ten months meant the lots had reached hospital shelves before anyone could pull them.

Under an open aseptic-processing warning letter, a second particulate recall in three weeks stops being bad luck: sterile-injectable quality failures repeat until the root cause is fixed.

Hospitals and ECT programs were told to quarantine both lots immediately and coordinate returns through Inmar; the company is notifying wholesale accounts in writing. No adverse events had been reported, FDA's recall classification was still pending, and the April 2026 warning letter covering the company's aseptic processing remained open.