Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nebivolol Tablets Recalled by Aurobindo Pharma USA Inc Due to CGMP Deviations: Presence of Nitrosamine Drug Substance Related...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aurobindo Pharma USA Inc directly.
Affected Products
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
Why Was This Recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aurobindo Pharma USA Inc
Aurobindo Pharma USA Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report