# FDA recall D-0669-2017

> **Jubilant Cadista Pharmaceuticals, Inc.** · Class III · drug recall initiated 2016-04-08.

## Product

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD  21801, USA.

## Reason for recall

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0669-2017
- **Recalling firm:** Jubilant Cadista Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-08
- **Report date:** 2017-04-19
- **Termination date:** 2017-04-17

- **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-0669-2017

## Citation

> AI Analytics. FDA recall D-0669-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0669-2017. Source: US FDA. Licensed CC0.

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