Class II
Drug Recall: 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
Aurobindo Pharma USA Inc · December 6, 2024
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0149-2025
Status: ongoing
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