Quick answers
- What is Sevoflurane used for?
- The FDA-approved label (Ultane, AbbVie Inc., February 12, 2025) says: “ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sevoflurane have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sevoflurane?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sevoflurane been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started June 13, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Sevoflurane?
- 10 companies list prescription products of Sevoflurane in the FDA NDC Directory, including Piramal Critical Care Inc, AbbVie Inc. and Baxter Healthcare Corporation.
What Sevoflurane is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. …
— FDA label: Ultane, AbbVie Inc., effective February 12, 2025. Read the full label on DailyMed →
The FDA has 13 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.
The label quoted above has no boxed warning.
0 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Piramal Critical Care Inc3 products
- AbbVie Inc.2 products
- Baxter Healthcare Corporation2 products
- Baxter Healthcare Company2 products
- Sandoz Inc1 product
- Halocarbon Life Sciences, LLC1 product
- Shandong New Time Pharmaceutical Co., Ltd.1 product
- Bryant Ranch Prepack1 product
- Mullan Pharmaceutical Inc.1 product
- Lannett Company, Inc.1 product
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 |
|---|---|---|---|
| NDA020478 ULTANE | Abbvie | June 7, 1995 | 27, latest February 3, 2025 2025: Labeling · 2022: Labeling · 2022: Labeling |
Generic approvals (5)
- ANDA075895Baxter Hlthcare · July 2, 2002
- ANDA077867Piramal Critical · May 2, 2007
- ANDA078650Halocarbon Prods · November 19, 2007
- ANDA203793Shanghai Hengrui · November 3, 2015
- ANDA214382Shandong · August 18, 2023
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 13, 2019 · Class II · Terminated · D-1435-2019
Failed Stability Specifications
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64 — Baxter Healthcare Corporation
-
January 22, 2018 · Class III · Terminated · D-0412-2018
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51 — AbbVie Inc.
-
April 7, 2014 · Class II · Terminated · D-1262-2014
Failed pH Specifications: product was too acidic.
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bethlehem, PA 18017. NDC: 66794-015-25. — Piramal Critical Care, Inc.
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) | 200243, 541963, 997625 |
|---|---|
| SPL set ID of the quoted label | c9aa6489-5a36-44ed-9512-b996833d82f7 |
| FDA labels (SPL) | 13 |
| FDA applications | NDA020478, 5 ANDA |
| Active ingredients (FDA) | SEVOFLURANE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ultane, AbbVie Inc., effective February 12, 2025; 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 →