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Class II

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

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

Recall number
D-0677-2026
Report date
July 22, 2026
Classification
Class II
Status in dataset
Ongoing
Recalling firm
Padagis US LLC
Generic names
NYSTATIN
Brand names
NYSTATIN
Product NDCs
45802-059

Code and lot information

Lot #: 205060, Exp 09/30/2027

Distribution

USA Nationwide

Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.

Source and limitations

This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on July 28, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.

Review the official FDA Drug Recalls page and the underlying openFDA query.