Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Aug 22, 2016 (10 years ago)

Daytrana (methylphenidate transdermal system)

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.

Cause type: Packaging defect

Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.

What was recalled

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 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 68968-5554-3.

Affected NDC 68968-5554-03

Compare with the code on your package — it is the most precise check available.

Drug: Methylphenidate

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Daytrana
methylphenidate
NDC 68968-5554		 20 mg/9h Patch
Transdermal		 Noven Therapeutics, LLC Rx · CII
Recalling firm
Noven Pharmaceuticals, Inc.
NDC code
68968-5554-3
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0429-2017 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Methylphenidate recalls

See all
Class II · Moderate risk

Methylphenidate Hydrochloride

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Terminated Dissolution failure Trigen Laboratories NDC 13811-708-10 D-0579-2024

Other recalls by Noven Pharmaceuticals, Inc.

All 2016 recalls
Class II · Moderate risk

Xelstrym (dextroamphetamine)

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Ongoing Packaging defect Noven Pharmaceuticals Inc NDC 68968-0215-3 D-0055-2025