# FDA recall D-0566-2016

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2015-11-12.

## Product

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.

## Reason for recall

Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0566-2016
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-11-12
- **Report date:** 2016-01-20
- **Termination date:** 2016-11-01

- **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-0566-2016

## Citation

> AI Analytics. FDA recall D-0566-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0566-2016. Source: US FDA. Licensed CC0.

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