US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 12, 2014 (12 years ago)

Bystolic

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

What was recalled

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

Recalling firm
Forest Pharmaceuticals Inc
NDC code
0456-1420-30
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1348-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Nebivolol recalls

See all
Class III · Low risk Ongoing

Nebivolol Tablets

Reason Cross Contamination with Other Products

Glenmark Pharmaceuticals Inc., USA NDC 42291-874-90 D-0222-2026
Class II · Moderate risk Ongoing

Nebivolol Tablets

Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Aurobindo Pharma USA Inc D-0149-2025
Class II · Moderate risk Terminated

Bystolic

Reason Failed Dissolution Specification; at the 6-month stability time point

Forest Pharmaceuticals Inc NDC 0456-1420-07 D-0036-2015
Class II · Moderate risk Terminated

Bystolic

Reason Failed Dissolution Specifications: Drug failed stage III dissolution testing.

Forest Pharmaceuticals Inc NDC 0456-1420-07 D-1412-2014
Class II · Moderate risk Terminated

Nebivolol HCL

Reason Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: AD73611_1, EXP: 5/30/2014; RASAGILINE MESYLATE, Tablet, 0.5 mg, NDC 68546014256, Pedigree: W002929, EXP: 6/10/2014.

Aidapak Services, LLC D-915-2014