Nebivolol Tablets recalled over manufacturing violations

Recall date

December 6, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hights…

Recall number

D-0149-2025

FDA classification

Class II

Brand / firm

Aurobindo Pharma USA Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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