# FDA recall D-0071-2023

> **Noven Pharmaceuticals Inc** · Class II · drug recall initiated 2022-11-16.

## Product

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

## Reason for recall

Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0071-2023
- **Recalling firm:** Noven Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-11-16
- **Report date:** 2022-12-07

- **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-0071-2023

## Citation

> AI Analytics. FDA recall D-0071-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0071-2023. Source: US FDA. Licensed CC0.

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