# FDA recall D-0263-2022

> **Aurobindo Pharma USA Inc.** · Class III · drug recall initiated 2021-11-15.

## Product

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0263-2022
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-11-15
- **Report date:** 2021-12-01
- **Termination date:** 2023-08-23

- **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-0263-2022

## Citation

> AI Analytics. FDA recall D-0263-2022. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0263-2022. Source: US FDA. Licensed CC0.

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