# FDA recall D-0429-2017

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2016-08-22.

## Product

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.

## Reason for recall

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

## Distribution

Nationwide within the US

## Key facts

- **Recall number:** D-0429-2017
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-22
- **Report date:** 2017-01-18
- **Termination date:** 2019-03-20

- **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-0429-2017

## Citation

> AI Analytics. FDA recall D-0429-2017. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0429-2017. Source: US FDA. Licensed CC0.

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