US Drug Recall Register
Class II · Moderate risk Ongoing Initiated May 20, 2021 (5 years ago)

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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 Noven Pharmaceuticals, Inc., Miami, FL 33186.

Recalling firm
Noven Pharmaceuticals Inc
NDC code
68968-5553-1
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0394-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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