Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Daytrana (Methylphenidate) Transdermal System Patch Recalled by Noven Pharmaceuticals, Inc. Due to Miscalibrated/Defective Delivery System; exceeded the specification for both...
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 Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
Quantity: 185,160 patches
Why Was This Recalled?
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Noven Pharmaceuticals, Inc.
Noven Pharmaceuticals, Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report