Quick answers
- What is Vigabatrin used for?
- The FDA-approved label (Sabril, Lundbeck Pharmaceuticals LLC, October 20, 2021) says: “SABRIL is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Vigabatrin have a boxed warning?
- Yes. The FDA label for Sabril has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Vigabatrin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated October 16, 2026). Ask your pharmacist about alternatives.
- Has Vigabatrin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 17, 2023 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Vigabatrin?
- 16 companies list prescription products of Vigabatrin in the FDA NDC Directory, including Upsher-Smith Laboratories, LLC, Lundbeck Pharmaceuticals LLC and Zydus Lifesciences Limited.
What Vigabatrin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SABRIL is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments …
— FDA label: Sabril, Lundbeck Pharmaceuticals LLC, effective October 20, 2021. Read the full label on DailyMed →
The FDA has 23 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 →
23 of 23 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.
- Upsher-Smith Laboratories, LLC3 products
- Lundbeck Pharmaceuticals LLC2 products
- Zydus Lifesciences Limited2 products
- Aurobindo Pharma Limited2 products
- Amneal Pharmaceuticals NY LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Dr.Reddys Laboratories Inc2 products
- Novadoz Pharmaceuticals LLC1 product
- Actavis Pharma, Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Edenbridge Pharmaceuticals LLC.1 product
- Par Health USA, LLC1 product
- Carnegie Pharmaceuticals LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- Cipla USA Inc.1 product
- Ascend Laboratories, LLC1 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 |
|---|---|---|---|
| NDA020427 SABRIL | Lundbeck Pharms LLC | August 21, 2009 | 22, latest March 18, 2026 2026: REMS · 2024: REMS · 2022: REMS |
| NDA022006 SABRIL | Lundbeck Pharms LLC | August 21, 2009 | 21, latest March 18, 2026 2026: REMS · 2024: REMS · 2022: REMS |
| NDA217684 VIGAFYDE | Pyros Pharms | June 17, 2024 | 4, latest March 18, 2026 2026: REMS · 2025: Labeling · 2025: Efficacy |
Generic approvals (18)
- ANDA208218Ph Health · April 27, 2017
- ANDA210155Amneal Pharms · March 13, 2018
- ANDA210196Bora · June 21, 2018
- ANDA211481DR Reddys · November 20, 2018
- ANDA209822Teva Pharms USA · January 14, 2019
- ANDA211592Invagen Pharms · December 3, 2019
- ANDA213375Alkem Labs Ltd · December 2, 2020
- ANDA213519Annora Pharma · January 26, 2021
- ANDA211539DR Reddys · January 29, 2021
- ANDA215109Dexcel · September 23, 2021
- ANDA213899Aurobindo Pharma Ltd · September 29, 2021
- ANDA215707Zydus Lifesciences · January 19, 2022
- ANDA215601Aurobindo Pharma Ltd · May 10, 2022
- ANDA213104Hikma · August 29, 2022
- ANDA215363Msn · September 7, 2022
- ANDA214671Zydus Lifesciences · March 2, 2023
- ANDA215519Carnegie · April 28, 2023
- ANDA214749Upsher Smith Labs · June 29, 2023
Shortage status
To be discontinued · updated October 16, 2026 · first posted October 16, 2026
| Product | Vigabatrin, Tablet, 500 mg (NDC 0054-0652-25) |
|---|---|
| Company | Hikma Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
November 17, 2023 · Class I · Completed · D-0220-2024
Defective Container: powder may leak out of the pouch
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., War — InvaGen Pharmaceuticals, Inc.
-
August 17, 2023 · Class III · Completed · D-1142-2023
Cross contamination with other products
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65 — Lundbeck LLC
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sabril, Lundbeck Pharmaceuticals LLC, effective October 20, 2021; 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 →