# FDA recall D-1348-2014

> **Forest Pharmaceuticals Inc** · Class II · drug recall initiated 2014-05-12.

## Product

Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30

## Reason for recall

Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1348-2014
- **Recalling firm:** Forest Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-05-12
- **Report date:** 2014-05-28
- **Termination date:** 2016-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Earth City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1348-2014

## Citation

> AI Analytics. FDA recall D-1348-2014. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1348-2014. Source: US FDA. Licensed CC0.

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