Padagis US LLC recalls Nystatin Cream USP
- Recalling company
- Padagis US LLC
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 23, 2026
- Reported
- Jul 22, 2026
- Distribution
- USA Nationwide
- Status
- Ongoing
- Quantity
- 180,936 tubes
- Lot / codes
- Lot #: 205060, Exp 09/30/2027
- Company location
- Minneapolis, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0677-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0677-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.