FDAFDA · Food and drugs·Recall number D-0677-2026
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Published July 22, 2026 · Recall initiated: June 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NYSTATIN
- Manufacturer
- Padagis US LLC
- Distributor
- USA Nationwide
- Lot
- Lot #: 205060, Exp 09/30/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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