Bystolic — Class II drug recall D-0036-2015
Terminated recall by Forest Pharmaceuticals Inc, reported 2014-10-29, distributed nationwide. Failed Dissolution Specification; at the 6-month stability time point
| Recall number | D-0036-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Forest Pharmaceuticals Inc, Earth City, MO, United States |
| Recall initiated | 2014-09-26 |
| Classified | 2014-10-17 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2017-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 94,584 cartons |
| Reason classes | specification failure |
| NDC | 00456-1420-07 |
| Lot numbers | A369286 |
| Expiration dates | 2016-01-31 |
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
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-0036-2015. 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.