# FDA recall D-0651-2016

> **Perrigo Company PLC** · Class II · drug recall initiated 2016-01-18.

## Product

Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.

## Reason for recall

Labeling: label error on declared strength.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0651-2016
- **Recalling firm:** Perrigo Company PLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-18
- **Report date:** 2016-02-10
- **Termination date:** 2016-06-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allegan, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2016

## Citation

> AI Analytics. FDA recall D-0651-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0651-2016. Source: US FDA. Licensed CC0.

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