# FDA recall D-396-2014

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2013-11-26.

## Product

Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98

## Reason for recall

Failed Tablet/Capsule Specifications: There is a potential for broken tablets.

## Distribution

Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone

## Key facts

- **Recall number:** D-396-2014
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-26
- **Report date:** 2014-01-08
- **Termination date:** 2014-08-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-396-2014

## Citation

> AI Analytics. FDA recall D-396-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-396-2014. Source: US FDA. Licensed CC0.

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