# FDA recall D-0207-2017

> **Zydus Pharmaceuticals USA Inc** · Class III · drug recall initiated 2016-11-02.

## Product

BuPROPion Hydrochloride Extended-Release Tablets (XL),  300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and  b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

## Reason for recall

Failed Dissolution Specifications; 6 month time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0207-2017
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-02
- **Report date:** 2016-12-28
- **Termination date:** 2020-07-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0207-2017

## Citation

> AI Analytics. FDA recall D-0207-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0207-2017. Source: US FDA. Licensed CC0.

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