# FDA recall D-847-2013

> **Teva Pharmaceuticals USA, Inc.** · Class II · drug recall initiated 2013-06-18.

## Product

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01

## Reason for recall

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-847-2013
- **Recalling firm:** Teva Pharmaceuticals USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-18
- **Report date:** 2013-08-14
- **Termination date:** 2014-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sellersville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-847-2013

## Citation

> AI Analytics. FDA recall D-847-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-847-2013. Source: US FDA. Licensed CC0.

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