# FDA recall D-0230-2018

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2017-11-03.

## Product

bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05

## Reason for recall

Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.

## Distribution

Product was distributed nationwide in the USA

## Key facts

- **Recall number:** D-0230-2018
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-03
- **Report date:** 2018-01-31
- **Termination date:** 2018-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2018

## Citation

> AI Analytics. FDA recall D-0230-2018. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/D-0230-2018. Source: US FDA. Licensed CC0.

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