# FDA recall D-0367-2019

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2018-12-31.

## Product

Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.

## Reason for recall

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

## Distribution

Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-0367-2019
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2018-12-31
- **Report date:** 2019-01-23

- **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-0367-2019

## Citation

> AI Analytics. FDA recall D-0367-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0367-2019. Source: US FDA. Licensed CC0.

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