# FDA recall D-0472-2023

> **Noven Pharmaceuticals Inc** · Class II · drug recall initiated 2023-03-10.

## Product

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC  68968-5554-3.

## Reason for recall

Defective Delivery System: Out of specification for shear.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-0472-2023
- **Recalling firm:** Noven Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-03-10
- **Report date:** 2023-03-29

- **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-0472-2023

## Citation

> AI Analytics. FDA recall D-0472-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0472-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*