Class II · ModerateActive recall

Nebivolol

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?

Check your lot numberLot #: NB0224001A and NB0224001B, Exp. Date 04/2027

Where it was soldNationwide in the USA

Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

Check the lot number and expiry on your medicine against the recall above.
Talk to your pharmacist or doctor before changing anything — don't stop on your own.
Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAurobindo Pharma Limited

Brand name	NEBIVOLOL
Generic name	NEBIVOLOL
Active ingredient(s)	NEBIVOLOL HYDROCHLORIDE
Distributed by / for	Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520
NDC	59651-137-30

Show the full FDA record

Full product label	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
Recalling firm	Aurobindo Pharma USA Inc
Distribution	Nationwide in the USA
Recall initiated	2024-12-06
Report date	2024-12-25
Recall completed	—
Recall number	D-0149-2025
Classification	Class II
FDA status	Ongoing
Origin on file	East Windsor NJ United States

Recent drug recalls Check another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.