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 NB0224001B
    • Exp. 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 4:18 PM UTC

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