FDA Drug recall D-1608-2014

Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patch…

FDA Drug
Class II
terminated
Published 2014-10-01

On 2014-10-01 the FDA classified a Class II recall of Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patch… by Noven Pharmaceuticals, citing defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remo….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1608-2014
Classification	Class II
Status	terminated
Initiated	2014-07-15
Published	2014-10-01
Last updated	2026-09-13 11:51 UTC
Company	Noven Pharmaceuticals
Distribution	US

Product

Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.

Reason

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Identifiers

ndc	68968-5552-3
ndc	68968-5553-3
ndc	68968-5554-3
ndc	68968-5555-3
code_info	Lot # 71165; Exp. 12/14

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1608-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.