# FDA recall D-1438-2016

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2015-12-21.

## Product

Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 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 68968-5553-3.

## Reason for recall

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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1438-2016
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-21
- **Report date:** 2016-07-20
- **Termination date:** 2019-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1438-2016

## Citation

> AI Analytics. FDA recall D-1438-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1438-2016. Source: US FDA. Licensed CC0.

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