# FDA recall D-0446-2017

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2016-12-20.

## Product

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India   NDC 47335-0738-86

## Reason for recall

Failed Dissolution Specifications; 18 month stability time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0446-2017
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-20
- **Report date:** 2017-02-01
- **Termination date:** 2018-07-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0446-2017

## Citation

> AI Analytics. FDA recall D-0446-2017. Retrieved 2026-05-30 from https://api.ai-analytics.org/recall/D-0446-2017. Source: US FDA. Licensed CC0.

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