Limited official informationFDA Drug Enforcement ReportsRecall date: Jul 22, 2026

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-05...

Full official product description

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

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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

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
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 #: 205060, Exp 09/30/2027	180,936 tubes	D-0677-2026

The agency's statement is shown without a site-authored severity score.

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

Agency classification: Class II

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

The linked agency record controls if any information differs.

Official scope

USA Nationwide

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.