Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Daytrana (methylphenidate transdermal system) Recalled by Noven Pharmaceuticals, Inc. Due to Defective Delivery System: Out of specification for z-statistic...

Date: July 27, 2015
Company: Noven Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Noven Pharmaceuticals, Inc. directly.

Affected Products

Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3

Quantity: 125,250 Patches

Why Was This Recalled?

Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Noven Pharmaceuticals, Inc.

Noven Pharmaceuticals, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report