Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst
Recalled December 25, 2024 · FDA recall D-0149-2025 · Aurobindo Pharma USA
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. · FDA Class II
Sold at
Nationwide in the USA
Description
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
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
Manufacturer(s)
Aurobindo Pharma USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →