US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 22, 2016 (10 years ago)

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3…

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

Why it was recalled

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

What was recalled

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.

Recalling firm
Noven Pharmaceuticals, Inc.
NDC code
68968-5555-3
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0430-2017

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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