Recalls / Class II
Class IID-0149-2025
Product
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
- Brand name
- Nebivolol
- Generic name
- Nebivolol
- Active ingredient
- Nebivolol Hydrochloride
- Route
- Oral
- NDCs
- 59651-137, 59651-138, 59651-139, 59651-140
- FDA application
- ANDA211053
- Affected lot / code info
- Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-12-06
- FDA classified
- 2024-12-16
- Posted by FDA
- 2024-12-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0149-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.