Reported Dec 25, 2024 · Ongoing
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Aurobindo Pharma USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only
- Distributed byAurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520
- NDC59651-137-30
- Lot codes and dates
Lot #: NB0224001A and NB0224001BExp. Date 04/2027
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
This product could cause temporary or reversible health problems — stop using it.
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