# FDA recall D-0394-2021

> **Noven Pharmaceuticals Inc** · Class II · drug recall initiated 2021-05-20.

## Product

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.

## Reason for recall

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0394-2021
- **Recalling firm:** Noven Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2021-05-20
- **Report date:** 2021-06-02

- **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-0394-2021

## Citation

> AI Analytics. FDA recall D-0394-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0394-2021. Source: US FDA. Licensed CC0.

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