Recall: D-0677-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-23Initiated

OngoingStatus

Padagis US LLCFirm

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

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

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.