Quick answers
- What is Methohexital sodium used for?
- The FDA-approved label (Brevital Sodium, Par Health USA, LLC, May 5, 2026) says: “BREVITAL can be used in adults as follows: 1. For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; BREVITAL may be given by infusion or intermittent injection. 3. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methohexital sodium have a boxed warning?
- Yes. The FDA label for Brevital Sodium has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Methohexital sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methohexital sodium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 7, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Methohexital sodium?
- 3 companies list prescription products of Methohexital sodium in the FDA NDC Directory, including Par Health USA, LLC, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. and Onesource Specialty Pharma Limited.
What Methohexital sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BREVITAL can be used in adults as follows: 1. For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; BREVITAL may be given by infusion or intermittent injection. 3. …
— FDA label: Brevital Sodium, Par Health USA, LLC, effective May 5, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous · Intramuscular · Rectal |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Brevital Sodium |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA011559 BREVITAL SODIUM | Ph Health | June 27, 1960 | 24, latest November 3, 2020 2020: Labeling · 2017: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (1)
- ANDA215488Onesource Specialty · October 3, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 7, 2026 · Class II · Ongoing · D-0662-2026
Failed Impurities/Degradation Specifications
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ — ONESOURCE SPECIALTY PHARMA LIMITED
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1244233, 1244638 |
|---|---|
| SPL set ID of the quoted label | eccd8340-ead3-4363-8902-0c19d33aa2ac |
| FDA labels (SPL) | 3 |
| FDA applications | NDA011559, 1 ANDA |
| Active ingredients (FDA) | METHOHEXITAL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Brevital Sodium, Par Health USA, LLC, effective May 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →