# FDA recall D-0840-2016

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2016-02-12.

## Product

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

## Reason for recall

Failed Dissolution Specifications; three month stability time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0840-2016
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-12
- **Report date:** 2016-05-18
- **Termination date:** 2016-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0840-2016

## Citation

> AI Analytics. FDA recall D-0840-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0840-2016. Source: US FDA. Licensed CC0.

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