ANNOUNCED ONGOING Drug recall · Reported 9 Oct 2026 · FDA company announcement, classification pending
Par Pharmaceutical Brevital Sodium 500 mg/vial for Injection recalled
Par Health is recalling Par Pharmaceutical Brevital Sodium 500 mg/vial for Injection, distributed nationwide in the US. The recall was initiated on 8 Oct 2026 and is listed as ongoing.
Recall details
- Recall number
- FDA-PR-744730720d79
- Recalling firm
- Par Health
- Brand
- Par Pharmaceutical
- Classification
- Pending
- Status
- Ongoing
- Recall initiated
- 8 Oct 2026
- Reported
- 9 Oct 2026
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Oct 2026 | Recall initiated by company | |
| 9 Oct 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter identified as cellulose. 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 Size Item Code Lot Numbers Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), Distributed by: Par Pharmaceutical* 42023-105-01 86930 02/2028 88623 04/2028 These lots were distributed nationwide to wholesalers between Ju
Product as listed by the company
Par Pharmaceutical Brevital Sodium 500 mg/vial for Injection
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter identified as cellulose. 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 Size Item Code Lot Numbers Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), Distributed by: Par Pharmaceutical* 42023-105-01 86930 02/2028 88623 04/2028 These lots were distributed nationwide to wholesalers between Ju
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does an unclassified recall mean?
The FDA assigns a class once it has assessed the health risk. Until then the recall is listed without one.
Read the official FDA notice · Source record retrieved 9 Oct 2026. This is a company announcement published by the FDA; the FDA has not yet classified the recall. The record is updated when the classification appears in the Enforcement Report. This page reports the record and gives no medical advice.
More recalls from Par Health
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | ANNOUNCED | Par Pharmaceutical Dexmedetomidine HCl recalled by Par HealthPar Pharmaceutical | Par Health | Particulate Matter | Nationwide |