FDA Recall D-0149-2025

Aurobindo Pharma USA Inc · East Windsor, NJ

Class II Ongoing 524 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027

Reason for recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Recall record

Recall number: D-0149-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-12-06
Classified by FDA Center: 2024-12-16
FDA published: 2024-12-25
Recalling firm: Aurobindo Pharma USA Inc
Firm location: East Windsor, NJ

Drug identification

Brand name(s): NEBIVOLOL
Generic name(s): NEBIVOLOL
Manufacturer(s): Aurobindo Pharma Limited
NDC(s): 59651-137, 59651-138, 59651-139, 59651-140
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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