# FDA recall D-0983-2017

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2017-06-29.

## Product

Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56

## Reason for recall

Failed Impurities/Degradation Specifications:  out of specification test results for related compounds largest unknown impurity.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0983-2017
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-06-29
- **Report date:** 2017-07-26
- **Termination date:** 2018-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Wales, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0983-2017

## Citation

> AI Analytics. FDA recall D-0983-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0983-2017. Source: US FDA. Licensed CC0.

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