CLASS II Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Bystolic (nebivolol), 20 mg/tablet recalled by Forest Pharmaceuticals
Forest Pharmaceuticals is recalling Bystolic (nebivolol), 20 mg/tablet per, distributed nationwide in the US. The recall was initiated on 12 May 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1348-2014
- FDA event ID
- 68246
- Recalling firm
- Forest Pharmaceuticals, Earth City, MO
- Brand
- Bystolic
- Manufacturer
- Allergan, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2014
- FDA classified
- 22 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 12 May 2014 | Recall initiated by company | |
| 22 May 2014 | Classified by FDA | +10 days |
| 28 May 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot: A287945, Exp: 08/2015
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Forest Pharmaceuticals
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bystolic (nebivolol) tablets, 20 mg/tablet recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Bystolic (nebivolol) tablets, 20 mg/tablet recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Namenda XR (memantine HCl), titration pack (7 mg, 14 mg recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Namenda XR (memantine HCl), sample pack, 28 mg recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Namenda XR (memantine HCl) recalled by Forest Pharmaceuticals | Forest Pharmaceuticals | Potency & Assay | Nationwide |
Other Nebivolol recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Nebivolol HCL, Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |