# FDA recall D-0163-2016

> **Valeant Pharmaceuticals North America LLC** · Class II · drug recall initiated 2015-09-04.

## Product

Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130.  NDC: 68012-495-90.

## Reason for recall

Failed Dissolution Specifications: Failed 24 month dissolution testing.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0163-2016
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-04
- **Report date:** 2015-11-11
- **Termination date:** 2017-03-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2016

## Citation

> AI Analytics. FDA recall D-0163-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0163-2016. Source: US FDA. Licensed CC0.

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