# FDA recall D-0826-2016

> **Impax Laboratories, Inc.** · Class II · drug recall initiated 2016-03-14.

## Product

Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0826-2016
- **Recalling firm:** Impax Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-14
- **Report date:** 2016-04-27
- **Termination date:** 2018-02-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Middlesex, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0826-2016

## Citation

> AI Analytics. FDA recall D-0826-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0826-2016. Source: US FDA. Licensed CC0.

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