# FDA recall D-1086-2015

> **Noven Pharmaceuticals, Inc.** · Class II · drug recall initiated 2015-01-12.

## Product

Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3

## Reason for recall

Defective Delivery System: One lot exceeded the mechanical peel specification

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1086-2015
- **Recalling firm:** Noven Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-01-12
- **Report date:** 2015-06-03
- **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-1086-2015

## Citation

> AI Analytics. FDA recall D-1086-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1086-2015. Source: US FDA. Licensed CC0.

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