CLASS II Drug recall · Reported 29 Oct 2014 · FDA Enforcement Report
Bystolic (nebivolol) tablets, 20 mg/tablet recalled
Forest Pharmaceuticals is recalling Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as/carton, and/trays, Professional, distributed nationwide in the US. The recall was initiated on 26 Sep 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-0036-2015
- FDA event ID
- 69298
- Recalling firm
- Forest Pharmaceuticals, Earth City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2014
- FDA classified
- 17 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 26 Sep 2014 | Recall initiated by company | |
| 17 Oct 2014 | Classified by FDA | +21 days |
| 29 Oct 2014 | Published in enforcement report | +12 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 Specification; at the 6-month stability time point
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) 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
Where it was distributed
Nationwide including Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Dissolution Specification; at the 6-month stability time point
Which lots are affected?
Lot A369286, exp. date 31 Jan 2016
Where was it sold?
Nationwide including 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), 20 mg/tablet recalled by Forest PharmaceuticalsBystolic | 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 Bystolic (nebivolol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bystolic (nebivolol) tablets, 20 mg/tablet recalled | Forest Pharmaceuticals | Potency & Assay | Nationwide |