Par Pharmaceutical Brevital Sodium Recall Over Particulate Contamination
Urgent safety alert: Par Pharmaceutical has issued a voluntary, nationwide recall of two lots of Brevital Sodium 500 mg/vial (methohexital for injection) after routine testing detected cellulose particles in the vials. Administering contaminated Brevital Sodium can lead to life-threatening blood-vessel blockages and severe inflammation. Hospitals, distributors, and clinicians must immediately quarantine the affected lots and arrange product returns—do not administer these vials to patients.
Brevital Sodium Recall Details
- Recall announced: 08 Oct 2026 (FDA posted 09 Oct 2026)
- Product: Brevital Sodium 500 mg/vial CIV (methohexital sodium for injection, USP)
- Manufacturer/Brand: Par Pharmaceutical (Par Health)
- Reason: Cellulose particulate matter observed in vials
- Distribution window: July 2025 – May 2026, United States
- Indications: Ultra-short-acting barbiturate anesthetic for adult IV induction and pediatric IM induction
Sources
Affected Brevital Sodium Lot Numbers
| Item Code | Lot | Expiration Date |
|---|---|---|
| 42023-105-01 | 86930 | 02/2028 |
| 42023-105-01 | 88623 | 04/2028 |
Examine the printed lot code on each vial’s label. If it matches 86930 or 88623, discontinue use and follow the return steps below.
Health Risks Posed by Contaminated Brevital Sodium
Injecting particulate matter can cause:
- Pulmonary embolism (blocked lung blood vessels)
- Systemic vessel occlusion leading to tissue necrosis or organ damage
- Phlebitis, thrombosis, and severe inflammatory responses
No injuries have been reported to date, yet the potential harm is classified as life-threatening.
Immediate Actions for Hospitals, Pharmacies & Distributors
- Quarantine and halt distribution of Brevital Sodium lots 86930 and 88623.
- Arrange product return by contacting Inmar, Inc. at 1-844-774-1187 (Mon–Fri, 9 a.m.–5 p.m. ET) or rxrecalls@inmar.com.
- Notify all downstream locations or accounts that may have received the recalled vials.
- Report adverse events to FDA MedWatch online at fda.gov/MedWatch/report.htm, by mail/fax, or by calling 1-800-332-1088.
Official Brevital Sodium Recall Images
Frequently Asked Questions
Why is Par Pharmaceutical recalling Brevital Sodium anesthetic vials?
Par Pharmaceutical’s quality testing detected cellulose particles in two lots of Brevital Sodium 500 mg/vial. Particulates can obstruct blood vessels and endanger patients, prompting the nationwide voluntary recall.
Which Brevital Sodium lot numbers are included in the 2026 recall?
Only lot numbers 86930 (expires 02/2028) and 88623 (expires 04/2028) are affected. No other lots or Par Pharmaceutical products are involved.
What health risks does contaminated Brevital Sodium pose to patients?
Injecting Brevital Sodium containing cellulose particles may cause pulmonary emboli, organ ischemia, vein inflammation, and other life-threatening complications.
What should hospitals do with recalled Brevital Sodium vials?
Quarantine unused vials immediately, stop distribution, and coordinate returns with Inmar, Inc. at 1-844-774-1187 or rxrecalls@inmar.com to receive credit or replacement instructions.
How can clinicians report Brevital Sodium adverse events to the FDA?
File a report through the FDA MedWatch portal (fda.gov/MedWatch/report.htm), by fax to 1-800-FDA-0178, or request a mail-in form via 1-800-332-1088.
Is uncontaminated Brevital Sodium inventory currently available?
Par Health has not announced replacement supply. Facilities should consult group purchasing organizations or alternative suppliers for methohexital sodium until unaffected lots are confirmed.
Has Par Pharmaceutical issued previous Brevital Sodium recalls?
No prior recalls for Brevital Sodium have been posted by the FDA in the past five years, making this the first recent action related to particulate contamination.