FDAHealthJune 23, 2026
Padagis US LLC — 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
⚠️ Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 23, 2026
USA Nationwide
What's affected?
- 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
- Brand
- NYSTATIN
- Lot code
- 205060
Additional details
Lot #: 205060, Exp 09/30/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 180,936 tubes.
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