Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Nystatin Recalled by Perrigo Company PLC Due to Labeling: label error on declared strength.

Date: January 18, 2016
Company: Perrigo Company PLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Perrigo Company PLC directly.

Affected Products

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

Quantity: 948 units

Why Was This Recalled?

Labeling: label error on declared strength.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Perrigo Company PLC

Perrigo Company PLC has 106 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report