# FDA recall D-0517-2017

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2017-02-07.

## Product

Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0517-2017
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-07
- **Report date:** 2017-03-22
- **Termination date:** 2018-02-16

- **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-0517-2017

## Citation

> AI Analytics. FDA recall D-0517-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0517-2017. Source: US FDA. Licensed CC0.

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