Data Composite

Recall D-0677-2026

US Class II Ongoing · initiated 2026-06-23

Recalling firm

Padagis US LLC, MN

Product

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

Reason for recall

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

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