FDA Drug recall D-0036-2015
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest…
- FDA Drug
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest… by Forest Pharmaceuticals, citing failed Dissolution Specification; at the 6-month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0036-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-26 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Forest Pharmaceuticals |
| Distribution | US |
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
Failed Dissolution Specification; at the 6-month stability time point
Identifiers
| code_info | Lot A369286, exp. date 31 Jan 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0036-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.