# FDA recall D-0007-2017

> **Sun Pharmaceutical Industries, Inc.** · Class III · drug recall initiated 2016-09-13.

## Product

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868  NDC 47335-737-86

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0007-2017
- **Recalling firm:** Sun Pharmaceutical Industries, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-13
- **Report date:** 2016-10-12
- **Termination date:** 2018-07-02

- **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-0007-2017

## Citation

> AI Analytics. FDA recall D-0007-2017. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0007-2017. Source: US FDA. Licensed CC0.

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