FDAFDA · Food and drugs·Recall number D-0149-2025
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
Published December 25, 2024 · Recall initiated: December 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NEBIVOLOL
- Manufacturer
- Aurobindo Pharma USA Inc
- Distributor
- Nationwide in the USA
- UPC
- 0359651137307
- Lot
- Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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