# FDA recall D-0989-2018

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2018-07-16.

## Product

Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.

## Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

## Distribution

Product was distributed throughout the United States, including Hawaii and Puerto Rico

## Key facts

- **Recall number:** D-0989-2018
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2018-07-16
- **Report date:** 2018-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Wales, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0989-2018

## Citation

> AI Analytics. FDA recall D-0989-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0989-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*