# FDA recall D-0137-2017

> **Amerisource Health Services** · Class III · drug recall initiated 2016-10-27.

## Product

Bupropion Hydrochloride Extended-Release Tablets, USP  (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05),  b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India  For BluePoint Laboratories

## Reason for recall

Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0137-2017
- **Recalling firm:** Amerisource Health Services
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-10-27
- **Report date:** 2016-11-23
- **Termination date:** 2017-06-29

- **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-0137-2017

## Citation

> AI Analytics. FDA recall D-0137-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0137-2017. Source: US FDA. Licensed CC0.

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