# FDA recall D-1104-2018

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class III · drug recall initiated 2018-08-14.

## Product

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90

## Reason for recall

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

## Distribution

Product was distributed throughout the United States to wholesalers and retailers.

## Key facts

- **Recall number:** D-1104-2018
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-14
- **Report date:** 2018-08-29
- **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-1104-2018

## Citation

> AI Analytics. FDA recall D-1104-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1104-2018. Source: US FDA. Licensed CC0.

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