Quick answers
- What is Sabril?
- Sabril is a brand name of Vigabatrin, a prescription medicine. The FDA NDC Directory lists 2 Sabril products in 2 strengths and forms.
- Who makes Sabril?
- Lundbeck Pharms LLC holds the FDA application for Sabril (NDA020427, approved August 21, 2009).
- Is there a generic or store brand of Sabril?
- Yes. The FDA NDC Directory lists 10 other products with the same active ingredients, strength and form as a Sabril product, 10 of them generic. Ask your pharmacist whether one is right for you.
- Has Sabril been recalled?
- FDA enforcement reports list 1 recall of Sabril products; the newest started August 17, 2023. A recall usually concerns specific lots, not every product.
What Sabril is
Each Sabril product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Vigabatrin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| vigabatrin 50 mg/mL powder, for solution (oral) | Sabril | 5 products, 5 companies | DailyMed |
| vigabatrin 500 mg tablet, film coated (oral) | Sabril | 5 products, 5 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Vigabatrin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Sabril
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Sabril products.
- Lundbeck Pharmaceuticals LLC2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.