# FDA recall D-0876-2018

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class III · drug recall initiated 2018-05-25.

## Product

Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90

## Reason for recall

Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).

## Distribution

IN, MI, MS, NC, NJ, NY and OH

## Key facts

- **Recall number:** D-0876-2018
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-25
- **Report date:** 2018-06-13
- **Termination date:** 2020-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salisbury, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0876-2018

## Citation

> AI Analytics. FDA recall D-0876-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0876-2018. Source: US FDA. Licensed CC0.

---

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