# FDA recall D-0519-2019

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class III · drug recall initiated 2019-02-28.

## Product

BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD

## Reason for recall

Failed Dissolution Specifications; 9-monthstability timepoint

## Distribution

Product was distributed to one customer who may have further distributed the product.

## Key facts

- **Recall number:** D-0519-2019
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-28
- **Report date:** 2019-03-13
- **Termination date:** 2020-03-05

- **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-0519-2019

## Citation

> AI Analytics. FDA recall D-0519-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0519-2019. Source: US FDA. Licensed CC0.

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