Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0149-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 6, 2024
- FDA report date
- Dec 25, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0149-2025, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95934
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
- Postal code
- 08520-1401
- Report date
- Dec 25, 2024
- Product type
- Drugs
- Recall number
- D-0149-2025
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc
- Reason for recall
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 6, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2024