# FDA recall D-0053-2015

> **Valeant Pharmaceuticals North America LLC** · Class III · drug recall initiated 2014-06-05.

## Product

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7

## Reason for recall

Labeling: Incorrect or Missing Package Insert

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0053-2015
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-06-05
- **Report date:** 2014-11-05
- **Termination date:** 2017-07-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2015

## Citation

> AI Analytics. FDA recall D-0053-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0053-2015. Source: US FDA. Licensed CC0.

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