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FDA · Drugs ·

Nystatin Cream USP, (100,000 USP Nystatin Units) recall

Padagis US LLC recalled Nystatin Cream USP, (100,000 USP Nystatin Units) on July 22, 2026 because of subpotent Drug: Low out of specification assay results performed during long-term stability testing. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 180,936 tubes

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Padagis US LLC, Minneapolis, MN
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
USA Nationwide
Status
Ongoing
Recall number
D-0677-2026
Source
U.S. Food and Drug Administration

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