# FDA recall D-0149-2025

> **Aurobindo Pharma USA Inc** · Class II · drug recall initiated 2024-12-06.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0149-2025
- **Recalling firm:** Aurobindo Pharma USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-06
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0149-2025

## Citation

> AI Analytics. FDA recall D-0149-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/D-0149-2025. Source: US FDA. Licensed CC0.

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