Quick answers
- What is Primidone used for?
- The FDA-approved label (Mysoline, Bausch Health US, LLC, September 10, 2026) says: “MYSOLINE, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Primidone have a boxed warning?
- No. None of the 26 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Primidone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Primidone been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started June 3, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Primidone?
- 22 companies list prescription products of Primidone in the FDA NDC Directory, including PD-Rx Pharmaceuticals, Inc., Advagen Pharma Limited and Aphena Pharma Solutions - Tennessee, LLC.
What Primidone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MYSOLINE, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
— FDA label: Mysoline, Bausch Health US, LLC, effective September 10, 2026. Read the full label on DailyMed →
The FDA has 26 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 26 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 42 in the FDA NDC Directory |
| Brand names | Mysoline |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| primidone 125 mg tablet | Generic | $1.39 per tablet |
| primidone 250 mg tablet | Generic | $0.2237 per tablet |
| primidone 50 mg tablet | Generic | $0.0924 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- PD-Rx Pharmaceuticals, Inc.4 products
- Advagen Pharma Limited3 products
- Aphena Pharma Solutions - Tennessee, LLC3 products
- NorthStar Rx LLC2 products
- American Health Packaging2 products
- Proficient Rx LP2 products
- AvKARE2 products
- AvPAK2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Amneal Pharmaceuticals LLC2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Bausch Health US, LLC2 products
- Oxford Pharmaceuticals, LLC2 products
- Bryant Ranch Prepack2 products
- Carnegie Pharmaceuticals LLC2 products
- Golden State Medical Supply, Inc.2 products
- Dr. Reddy's Laboratories Limited2 products
- Lannett Company, Inc.2 products
- Actavis Pharma, Inc.1 product
- TruPharma, LLC1 product
- Direct_Rx1 product
- Chartwell RX, 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 |
|---|---|---|---|
| NDA009170 MYSOLINE | Valeant | March 8, 1954 | 19, latest June 10, 2020 2020: Manufacturing (CMC) · 2016: Manufacturing (CMC) · 2011: REMS |
Generic approvals (7)
- ANDA084903Lannett · December 1, 1978
- ANDA083551Watson Labs · February 7, 1979
- ANDA040586Oxford Pharms · February 24, 2005
- ANDA040866Amneal Pharm · April 23, 2008
- ANDA040862Chartwell Rx · October 3, 2008
- ANDA214896Rubicon Research · June 28, 2022
- ANDA218366Carnegie · January 23, 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 3, 2026 · Class III · Ongoing · D-0585-2026
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, — Amneal Pharmaceuticals, LLC
-
May 1, 2026 · Class III · Ongoing · D-0536-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11 — Amerisource Health Services LLC
-
May 1, 2026 · Class III · Ongoing · D-0537-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 — Amerisource Health Services LLC
-
April 27, 2026 · Class III · Ongoing · D-0534-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 — Golden State Medical Supply Inc.
-
April 27, 2026 · Class III · Ongoing · D-0535-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 — Golden State Medical Supply Inc.
-
April 24, 2026 · Class III · Ongoing · D-0533-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. — Lannett Company 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mysoline, Bausch Health US, LLC, effective September 10, 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 →