Highest risk U.S. Food and Drug Administration

Par Pharmaceutical Brevital Sodium 500 mg/vial for Injection recall: Presence of particulate matter identified as cellulose

Recall published 25 days ago

Presence of particulate matter identified as cellulose

Par Pharmaceutical Prescription & OTC drugs — recalled prescription & otc drugsPar Pharmaceutical Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Administration of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
October 8, 2026
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Par Pharmaceutical
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Brevital Sodium 500 mg/vial for Injection

What the company announced

FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose.

Administration of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting. To date, Par Health has not received any reports of adverse events related to this recall.

Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) is formulated for intravenous infusion in adult patients or intramuscular induction in pediatric patients. The product is indicated as an ultra-short-acting barbiturate anesthetic primarily used for the induction of anesthesia and procedural sedation.

Recalled product can be identified as follows and by labels at bottom of this document:

  • Product: Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), Distributed by: Par Pharmaceutical* · Size: 42023-105-01 · Item Code: 86930 · Lot Numbers: 02/2028
  • Product: 88623 · Size: 04/2028

These lots were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026.

Par Health is providing written notification to wholesale accounts that have received the affected lots and are arranging for return of all existing inventory of Lots 86930 and 88623 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

Questions regarding this recall can be directed to Inmar, Inc. at 1-844-774-1187 Monday through Friday between the hours of 9 a.m. and 5 p.m. ET or by email at [email protected] .

For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393 Monday through Thursday between the hours of 9 a.m. and 8 p.m. ET or Friday between 9 a.m. and 6 p.m. ET.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Package Identification:

See examples of vial labels from the affected lots below:

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 02/2028
  • 86930
  • 88623

Model or item number

On the rating label, the box or the instruction sheet.

  • 86930
  • 88623

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Par Pharmaceutical — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Par Health — Consumers: Inmar, Inc., 1-844-774-1187, [email protected] — Media: Gena Holthaus, Senior Director, Corporate Brand and Communications, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Par Pharmaceutical prescription & otc drugs recalled?

Presence of particulate matter identified as cellulose Administration of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), found to contain particulate matter, has a reasonable probability of causing life-threatening adverse health consequences including pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or inflammation of the walls of veins, which may lead to clotting.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 02/2028, 86930, 88623; model number 86930, 88623. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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