# FDA recall D-1501-2016

> **Amerisource Health Services** · Class III · drug recall initiated 2016-08-04.

## Product

buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03

## Reason for recall

Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1501-2016
- **Recalling firm:** Amerisource Health Services
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-04
- **Report date:** 2016-09-21
- **Termination date:** 2017-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1501-2016

## Citation

> AI Analytics. FDA recall D-1501-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1501-2016. Source: US FDA. Licensed CC0.

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