Quick answers
- What is Rizatriptan benzoate used for?
- The FDA-approved label (Maxalt, Organon LLC, January 29, 2026) says: “MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rizatriptan benzoate have a boxed warning?
- The label we quote has no boxed warning, but 2 of 46 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Rizatriptan benzoate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Rizatriptan benzoate been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started July 9, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Rizatriptan benzoate?
- 23 companies list prescription products of Rizatriptan benzoate in the FDA NDC Directory, including Bryant Ranch Prepack, Direct_Rx and Proficient Rx LP.
What Rizatriptan benzoate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. …
— FDA label: Maxalt, Organon LLC, effective January 29, 2026. Read the full label on DailyMed →
The FDA has 46 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.
2 of 46 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, orally disintegrating · Tablet, film coated · Film |
|---|---|
| Route | Oral |
| Prescription products | 72 in the FDA NDC Directory |
| Brand names | Rizafilm, Maxalt-Mlt, Maxalt |
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 |
|---|---|---|
| rizatriptan benzoate 10 mg tablet | Generic | $0.3280 per tablet |
| rizatriptan benzoate 10 mg tablet | Brand: Maxalt | $44.25 per tablet |
| rizatriptan benzoate 10 mg tablet, film coated | Generic | $0.3280 per tablet |
| rizatriptan benzoate 10 mg tablet, orally disintegrating | Generic | $0.5216 per tablet |
| rizatriptan benzoate 10 mg tablet, orally disintegrating | Brand: Maxalt-Mlt | $44.23 per tablet |
| rizatriptan benzoate 5 mg tablet | Generic | $0.3437 per tablet |
| rizatriptan benzoate 5 mg tablet, film coated | Generic | $0.3437 per tablet |
| rizatriptan benzoate 5 mg tablet, orally disintegrating | Generic | $0.5591 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.
- Bryant Ranch Prepack9 products
- Direct_Rx8 products
- Proficient Rx LP4 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Aurobindo Pharma Limited4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Macleods Pharmaceuticals Limited4 products
- Rising Pharma Holdings, Inc.4 products
- A-S Medication Solutions4 products
- Panacea Biotec Limited2 products
- Cipla USA Inc.2 products
- Bionpharma Inc.2 products
- Asclemed USA, Inc.2 products
- Organon LLC2 products
- Ascend Laboratories, LLC2 products
- Creekwood Pharmaceuticals LLC2 products
- Gensco Laboratories LLC2 products
- Teva Pharmaceuticals USA, Inc.2 products
- Chartwell RX, LLC2 products
- NuCare Pharmaceuticals, Inc.1 product
- Remedyrepack Inc.1 product
- Advanced Rx of Tennessee, 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 |
|---|---|---|---|
| NDA020864 MAXALT | Organon LLC | June 29, 1998 | 17, latest October 1, 2019 2019: Labeling · 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA020865 MAXALT-MLT | Organon | June 29, 1998 | 18, latest October 1, 2019 2019: Labeling · 2014: Manufacturing (CMC) · 2011: Labeling |
| NDA205394 RIZAFILM | Gensco | April 14, 2023 | 3, latest February 26, 2026 2026: Efficacy · 2026: Labeling · 2023: Labeling |
Generic approvals (14)
- ANDA077263Teva Pharms · December 31, 2012
- ANDA201967Glenmark Pharms Ltd · December 31, 2012
- ANDA202047Pharmazone · December 31, 2012
- ANDA202490Aurobindo Pharma Ltd · December 31, 2012
- ANDA078739Chartwell Rx · July 1, 2013
- ANDA201914Glenmark Pharms Ltd · July 1, 2013
- ANDA203062Aurobindo Pharma Ltd · July 1, 2013
- ANDA204339Invagen Pharms · July 1, 2013
- ANDA203147Macleods Pharms · February 11, 2014
- ANDA203146Macleods Pharms Ltd · September 19, 2014
- ANDA203269Alkem Labs Ltd · February 18, 2016
- ANDA204722Panacea · January 11, 2017
- ANDA207835Unichem · March 7, 2017
- ANDA207836Unichem · March 7, 2017
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.
-
July 9, 2025 · Class II · Ongoing · D-0534-2025
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18 — Ascend Laboratories, LLC
-
July 9, 2025 · Class II · Ongoing · D-0533-2025
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18 — Ascend Laboratories, LLC
-
May 13, 2024 · Class II · Ongoing · D-0534-2024
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06 — Glenmark Pharmaceuticals Inc., USA
-
May 13, 2024 · Class II · Ongoing · D-0535-2024
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06 — Glenmark Pharmaceuticals Inc., USA
-
May 10, 2024 · Class II · Ongoing · D-0533-2024
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99 — Glenmark Pharmaceuticals Inc., USA
-
May 10, 2024 · Class II · Ongoing · D-0532-2024
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99 — Glenmark Pharmaceuticals Inc., USA
-
October 18, 2021 · Class III · Terminated · D-0079-2022
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutic — MACLEODS PHARMA USA, INC
-
October 18, 2021 · Class III · Terminated · D-0080-2022
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuti — MACLEODS PHARMA USA, INC
-
October 18, 2021 · Class III · Terminated · D-0078-2022
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Ma — MACLEODS PHARMA USA, 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) — Maxalt, Organon LLC, effective January 29, 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 →