FDA Drugs recall ·
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only… recall
- Recall number
- D-0149-2025
- Date
- (initiated December 6, 2024)
- Company / brand
- Aurobindo Pharma USA Inc
279 Princeton Hightstown Rd, East Windsor, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0149-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.