# FDA recall D-0579-2024

> **Trigen Laboratories** · Class II · drug recall initiated 2024-06-17.

## Product

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

## Reason for recall

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0579-2024
- **Recalling firm:** Trigen Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-06-17
- **Report date:** 2024-07-10
- **Termination date:** 2025-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0579-2024

## Citation

> AI Analytics. FDA recall D-0579-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0579-2024. Source: US FDA. Licensed CC0.

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