# FDA recall D-0021-2023

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2022-10-05.

## Product

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road  East Windsor, NJ 08520, Made in India, NDC 65862-162-90

## Reason for recall

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0021-2023
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2022-10-05
- **Report date:** 2022-11-02

- **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-0021-2023

## Citation

> AI Analytics. FDA recall D-0021-2023. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0021-2023. Source: US FDA. Licensed CC0.

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