Par Health Recalls Brevital Sodium Over Cellulose Particulate

Par Health is recalling two lots of Brevital Sodium, an injectable anesthetic used to induce general anesthesia and sedation, after finding particulate matter identified as cellulose in the product. The recall, posted by FDA on 9 October 2026, reaches the hospital level and covers lots shipped nationwide over a ten-month span. It is the company's second particulate-related recall of a sterile injectable in three weeks.

What's in the vial

Brevital Sodium is methohexital sodium, an ultra-short-acting barbiturate used to induce general anesthesia, to supplement other anesthetic agents, and — outside the operating room — to induce seizures for electroconvulsive therapy. It is a Schedule IV controlled substance administered intravenously, which puts any particulate contamination on a short, direct path to the bloodstream and lungs. Par Health's recall notice identifies the particulate as cellulose and assigns the recall to the hospital level, meaning the affected lots reach clinical users rather than stopping at a distribution warehouse.

A second recall, the same contaminant

This is not Par Health's first cellulose-related recall this autumn. On or around 18 September 2026, the company 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. Different drug, different lot numbers, same particulate signature, roughly three weeks apart. Neither recall notice draws a connection between the two events, and nothing public ties them to a single root cause. But for a quality or supply-chain team tracking a single manufacturer's sterile-injectables output, two particulate recalls from the same company inside a month is the kind of pattern worth watching rather than treating each event in isolation.

Who Par Health is

Par Health is the independent company formed from the combination of Mallinckrodt's and Endo's generics, API and sterile-injectables businesses, completing its spin-off on 10 November 2025. The company describes itself as a top-15 U.S. generic medicines manufacturer, the largest U.S. manufacturer of active pharmaceutical ingredients by volume, and a leading U.S. producer of sterile injectables, operating seven U.S. facilities plus additional sites in India. Brevital Sodium traces its manufacturing lineage to Par Pharmaceutical's sterile-products operations, a predecessor business folded into the new company.

What happens next

Par Health is notifying wholesale accounts in writing and coordinating the return of recalled product through Inmar, Inc. FDA had not posted a recall classification — Class I, II or III — as of this report; that determination typically follows a recall's initiation by several weeks and will set the formal severity rating for the agency's own enforcement records. Hospitals and pharmacies holding either lot should quarantine remaining stock and follow Par Health's return instructions rather than wait for the classification to post.

Frequently asked questions

What did Par Health recall, and why?

Two lots of Brevital Sodium 500 mg/vial CIV (methohexital sodium for injection, USP) — Lot 86930 (expires February 2028) and Lot 88623 (expires April 2028) — because of particulate matter identified as cellulose found in the product.

How far did the affected lots travel?

Par Health distributed both lots nationwide to wholesalers between July 8, 2025, and May 11, 2026. The recall reaches the hospital level; Par Health is notifying wholesale accounts in writing and coordinating returns through Inmar, Inc.

What is the health risk?

Par Health's notice states a reasonable probability that administering product containing particulate matter could cause serious, potentially life-threatening adverse health consequences, including pulmonary emboli, if the particles are injected intravenously and travel to the lungs. As of the recall notice, the company had not received any reports of adverse events tied to the affected lots.

Has FDA assigned a recall classification?

Not yet at the time of this report. FDA typically assigns a Class I, II or III classification in the weeks following a recall's initiation; none had been posted at publication.