# FDA recall D-0478-2017

> **Accord Healthcare, Inc.** · Class II · drug recall initiated 2016-12-20.

## Product

Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17

## Reason for recall

Failed tablet/capsule specification: missing break line on the 5mg tablet.

## Distribution

U.S. Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0478-2017
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-20
- **Report date:** 2017-02-22
- **Termination date:** 2017-08-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0478-2017

## Citation

> AI Analytics. FDA recall D-0478-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0478-2017. Source: US FDA. Licensed CC0.

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