Product: Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520.  NDC:  59651-137-30
Reason for recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Recall initiated: 20241206
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated