Quick answers
- What is Phenytoin used for?
- The FDA-approved label (Dilantin-125, Viatris Specialty LLC, February 2, 2023) says: “DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Phenytoin have a boxed warning?
- The label we quote has no boxed warning, but 9 of 49 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Phenytoin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Phenytoin been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started October 27, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Phenytoin?
- 29 companies list prescription products of Phenytoin in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Remedyrepack Inc. and Hikma Pharmaceuticals USA Inc..
What Phenytoin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
— FDA label: Dilantin-125, Viatris Specialty LLC, effective February 2, 2023. Read the full label on DailyMed →
The FDA has 49 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.
9 of 49 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, extended release · Injection · Tablet, chewable · Capsule · Suspension |
|---|---|
| Route | Oral · Intramuscular · Intravenous |
| Prescription products | 54 in the FDA NDC Directory |
| Brand names | Dilantin, Phenytek, Phenytoin Infatabs, Dilantin-125, Dilantin Infatabs |
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 |
|---|---|---|
| phenytoin 125 mg/5 mL suspension | Generic | $0.0743 per mL |
| phenytoin 50 mg tablet, chewable | Generic | $0.2316 per tablet |
| phenytoin 50 mg tablet, chewable | Brand: Dilantin Infatabs | $1.57 per tablet |
| phenytoin sodium 100 mg capsule | Generic | $0.1438 per capsule |
| phenytoin sodium 100 mg capsule, extended release | Generic | $0.1438 per capsule |
| phenytoin sodium 100 mg capsule, extended release | Brand: Dilantin | $1.74 per capsule |
| phenytoin sodium 200 mg capsule, extended release | Brand: Phenytek | $1.40 per capsule |
| phenytoin sodium 30 mg capsule, extended release | Brand: Dilantin | $1.50 per capsule |
| phenytoin sodium 300 mg capsule, extended release | Brand: Phenytek | $2.10 per capsule |
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.
- Sun Pharmaceutical Industries, Inc.5 products
- Remedyrepack Inc.5 products
- Hikma Pharmaceuticals USA Inc.4 products
- Viatris Specialty LLC3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Mylan Pharmaceuticals Inc.3 products
- American Health Packaging3 products
- A-S Medication Solutions2 products
- Coupler LLC2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Major Pharmaceuticals2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Henry Schein, Inc.2 products
- Direct_Rx1 product
- Medical Purchasing Solutions, LLC1 product
- Acella Pharmaceuticals, LLC1 product
- Amneal Pharmaceuticals LLC1 product
- Proficient Rx LP1 product
- AvPAK1 product
- Unichem Pharmaceuticals (USA), Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Bryant Ranch Prepack1 product
- Aurobindo Pharma Limited1 product
- ProPharma Distribution1 product
- Prasco Laboratories1 product
- Atlantic Biologicals Corp.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
- Rising Pharma Holdings, Inc.1 product
- Parke-Davis Div of Pfizer Inc1 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 |
|---|---|---|---|
| NDA008762 DILANTIN-125, DILANTIN-30 | Viatris | January 6, 1953 | 46, latest March 3, 2022 2022: Labeling · 2021: Labeling · 2019: Labeling |
Generic approvals (13)
- ANDA084307Hikma · July 16, 1975
- ANDA084349Viatris · August 27, 1976
- ANDA084427Pharmacia · February 26, 1979
- ANDA040298Mylan · December 28, 1998
- ANDA040521Taro · March 8, 2004
- ANDA040684Taro · September 5, 2006
- ANDA040573Acella · September 13, 2006
- ANDA040731Sun Pharm Inds · June 30, 2008
- ANDA040765Amneal Pharms Ny · November 12, 2008
- ANDA200691Rising · December 26, 2012
- ANDA200565Taro · April 17, 2014
- ANDA204309Aurobindo Pharma · June 10, 2015
- ANDA213834Unichem · October 13, 2022
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.
-
October 27, 2023 · Class II · Terminated · D-0090-2024
Failed Dissolution Specifications
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10 — Amneal Pharmaceuticals of New York, LLC
-
May 30, 2023 · Class II · Terminated · D-0876-2023
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10. — Amneal Pharmaceuticals of New York, LLC
-
November 14, 2022 · Class III · Terminated · D-0070-2023
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 — Acella Pharmaceuticals, LLC
-
November 14, 2022 · Class III · Terminated · D-0069-2023
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 — Acella Pharmaceuticals, LLC
-
February 7, 2020 · Class I · Terminated · D-0863-2020
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 516 — Taro Pharmaceuticals U.S.A., Inc.
-
August 17, 2013 · Class II · Terminated · D-66014-001
Failed dissolution specifications; 18 month CRT
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmac — Amneal Pharmaceuticals of New York, 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) — Dilantin-125, Viatris Specialty LLC, effective February 2, 2023; 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 →