# FDA recall D-1324-2014

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2014-04-07.

## Product

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.

## Reason for recall

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1324-2014
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-07
- **Report date:** 2014-05-28
- **Termination date:** 2014-11-20

- **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-1324-2014

## Citation

> AI Analytics. FDA recall D-1324-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1324-2014. Source: US FDA. Licensed CC0.

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