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Brand-name prescription medicine

Daytrana

Generic name: Methylphenidate

FDA application holder: Noven Pharms Inc

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

4Strengths and forms
0Same medicine, other names
2006FDA approval
42Recalls (FDA reports)

Quick answers

What is Daytrana?
Daytrana is a brand name of Methylphenidate, a prescription medicine. The FDA NDC Directory lists 4 Daytrana products in 4 strengths and forms.
Who makes Daytrana?
Noven Pharms Inc holds the FDA application for Daytrana (NDA021514, approved April 6, 2006).
Is there a generic or store brand of Daytrana?
Other products of Methylphenidate are listed with the FDA, but none in exactly the same strength and form as a Daytrana product.
Has Daytrana been recalled?
FDA enforcement reports list 42 recalls of Daytrana products; the newest started March 10, 2023. A recall usually concerns specific lots, not every product.

What Daytrana is

Each Daytrana 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.

Methylphenidate · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
methylphenidate 10 mg/9 h
patch (transdermal)		 Daytrana None listed DailyMed
methylphenidate 15 mg/9 h
patch (transdermal)		 Daytrana None listed DailyMed
methylphenidate 20 mg/9 h
patch (transdermal)		 Daytrana None listed DailyMed
methylphenidate 30 mg/9 h
patch (transdermal)		 Daytrana None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Methylphenidate →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Daytrana products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA021514Noven Pharms IncApril 6, 20064

Companies that list Daytrana

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Daytrana 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.

  1. March 10, 2023 · Class II · Ongoing · D-0471-2023

    Defective Delivery System: Out of specification for shear.

    Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3 — Noven Pharmaceuticals Inc

  2. March 10, 2023 · Class II · Ongoing · D-0473-2023

    Defective Delivery System: Out of specification for shear.

    Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3 — Noven Pharmaceuticals Inc

  3. March 10, 2023 · Class II · Ongoing · D-0470-2023

    Defective Delivery System: Out of specification for shear.

    Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3. — Noven Pharmaceuticals Inc

  4. March 10, 2023 · Class II · Ongoing · D-0472-2023

    Defective Delivery System: Out of specification for shear.

    Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3. — Noven Pharmaceuticals Inc

  5. November 16, 2022 · Class II · Ongoing · D-0071-2023

    Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

    Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 3 — Noven Pharmaceuticals Inc

  6. June 24, 2022 · Class II · Ongoing · D-1169-2022

    Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.

    Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 331 — Noven Pharmaceuticals Inc

  7. May 6, 2022 · Class II · Ongoing · D-0889-2022

    Defective Delivery System: customer complaints exceeded respective action limits.

    Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 3 — Noven Pharmaceuticals Inc

  8. May 20, 2021 · Class II · Ongoing · D-0393-2021

    Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

    Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By No — Noven Pharmaceuticals Inc

  9. May 20, 2021 · Class II · Ongoing · D-0394-2021

    Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

    Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By No — Noven Pharmaceuticals Inc

  10. February 19, 2021 · Class II · Terminated · D-0296-2021

    Defective Delivery System: Out of specification for mechanical peel.

    Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, — Noven Pharmaceuticals Inc

  11. February 19, 2021 · Class II · Terminated · D-0295-2021

    Defective Delivery System: Out of specification for mechanical peel.

    Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, — Noven Pharmaceuticals Inc

  12. February 19, 2021 · Class II · Terminated · D-0294-2021

    Defective Delivery System: Out of specification for mechanical peel.

    Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, — Noven Pharmaceuticals Inc

  13. February 19, 2021 · Class II · Terminated · D-0293-2021

    Defective Delivery System: Out of specification for mechanical peel.

    Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LL — Noven Pharmaceuticals Inc

  14. March 31, 2020 · Class II · Terminated · D-1248-2020

    Defective Delivery System: Out of specification for mechanical peel and shear.

    Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3 — Noven Therapeutics, LLC

  15. March 31, 2020 · Class II · Terminated · D-1249-2020

    Defective Delivery System: Out of specification for mechanical peel and shear.

    Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3 — Noven Therapeutics, LLC

Showing the newest 15 of 42.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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