Bystolic — Class II drug recall D-1348-2014
Terminated recall by Forest Pharmaceuticals Inc, reported 2014-05-28, distributed nationwide. Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test r
| Recall number | D-1348-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Forest Pharmaceuticals Inc, Earth City, MO, United States |
| Recall initiated | 2014-05-12 |
| Classified | 2014-05-22 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2016-01-05 |
| Distributed | Nationwide (US) |
| Quantity | 21,875 bottles |
| Reason classes | specification failure |
| NDC | 00456-1402, 00456-1402-01, 00456-1402-30, 00456-1402-63, 00456-1402-90, 00456-1405, 00456-1405-01, 00456-1405-30, 00456-1405-63, 00456-1405-90, 00456-1410, 00456-1410-01, 00456-1410-30, 00456-1410-63, 00456-1410-90, 00456-1420, 00456-1420-01, 00456-1420-30, 00456-1420-63, 00456-1420-90 |
| Lot numbers | A287945 |
| Expiration dates | 2015-08 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1348-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.