# FDA recall D-0036-2015

> **Forest Pharmaceuticals Inc** · Class II · drug recall initiated 2014-09-26.

## Product

Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. ---  NDC 0456-1420-07

## Reason for recall

Failed Dissolution Specification; at the 6-month stability time point

## Distribution

Nationwide including Puerto Rico.

## Key facts

- **Recall number:** D-0036-2015
- **Recalling firm:** Forest Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-09-26
- **Report date:** 2014-10-29
- **Termination date:** 2017-03-29

- **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-0036-2015

## Citation

> AI Analytics. FDA recall D-0036-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0036-2015. Source: US FDA. Licensed CC0.

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