Nebivolol Tablets — Class II drug recall D-0149-2025
Ongoing recall by Aurobindo Pharma USA Inc, reported 2024-12-25, distributed nationwide. CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above ac
| Recall number | D-0149-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc, East Windsor, NJ, United States |
| Recall initiated | 2024-12-06 |
| Classified | 2024-12-16 |
| Reported by FDA | 2024-12-25 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 59651-0137, 59651-0137-30, 59651-0137-90, 59651-0138, 59651-0138-30, 59651-0138-90, 59651-0139, 59651-0139-30, 59651-0139-90, 59651-0140, 59651-0140-30, 59651-0140-90 |
| Lot numbers | NB0224001A, NB0224001B |
| Expiration dates | 2027-04 |
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
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0149-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.