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

Recall Number: D-0677-2026

Firm: Padagis US LLC

Classification: Class II

Status: Ongoing

Report Date: 20260722

Initiation Date: 20260623

Termination Date:

Reason for Recall

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

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