# FDA recall D-1052-2019

> **Rising Pharmaceuticals, Inc.** · Class II · drug recall initiated 2019-03-07.

## Product

Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC,  Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30

## Reason for recall

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

## Distribution

Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-1052-2019
- **Recalling firm:** Rising Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2019-03-07
- **Report date:** 2019-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saddle Brook, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1052-2019

## Citation

> AI Analytics. FDA recall D-1052-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1052-2019. Source: US FDA. Licensed CC0.

---

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