FDA Drug recall D-1348-2014
Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharm…
- FDA Drug
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharm… by Forest Pharmaceuticals, citing failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf li….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1348-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-12 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Forest Pharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| ndc | 0456-1402-30 |
|---|---|
| ndc | 0456-1402-90 |
| ndc | 0456-1402-01 |
| ndc | 0456-1402-63 |
| ndc | 0456-1405-30 |
| ndc | 0456-1405-90 |
| ndc | 0456-1405-01 |
| ndc | 0456-1405-63 |
| ndc | 0456-1410-30 |
| ndc | 0456-1410-90 |
| ndc | 0456-1410-01 |
| ndc | 0456-1410-63 |
| ndc | 0456-1420-30 |
| ndc | 0456-1420-90 |
| ndc | 0456-1420-01 |
| ndc | 0456-1420-63 |
| code_info | Lot: A287945, Exp: 08/2015 |
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-1348-2014%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.