Reported Jul 22, 2026 · Ongoing

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham,…

Padagis US LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Padagis US LLC · 3940 Quebec Ave N · Minneapolis, MN · 55427-1244

Is this the product you have?

  • Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Lot codes and dates
    • Lot #: 205060
    • Exp 09/30/2027
Amount recalled
180,936 tubes

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 2:52 PM UTC

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