Nystatin Cream Recall Due to Low Potency Test Results
Padagis US LLC is recalling Nystatin Cream USP (100,000 USP units) because long-term stability testing found assay results below specification, meaning the product may contain less active ingredient than labeled.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The source text states no reported illnesses or injuries, and the hazard is a manufacturing defect (low assay/subpotency) detected during stability testing rather than an imminent safety threat. This meets the criteria for Moderate severity.
Plain-English summary
Padagis US LLC is recalling Nystatin Cream USP, 100,000 USP Nystatin Units, 15 g tubes, NDC 45802-059-35, Lot #205060 (expiration 09/30/2027), distributed nationwide in the USA. The recall was initiated after long-term stability testing revealed assay results out of specification, indicating the product may be subpotent—containing less active nystatin than the labeled amount.
Affected consumers who have purchased this product should stop use and consult their healthcare provider regarding their treatment options. The product is available only by prescription (Rx only). Consumers with questions about the recall should contact their pharmacist or healthcare provider.
The recalled product
- Product
- NYSTATIN (NYSTATIN)
- Brand
- NYSTATIN
- Manufacturer
- Padagis US LLC
- Category
- Drug — Topical Antifungal
- Hazard
- subpotency
- low-assay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 205060
- Exp 09/30/2027
Distribution
Distributed nationwide across the United States.
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