Nystatin Cream USP recall: Subpotent
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
Why was Nystatin Cream USP recalled?
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 205060, Exp 09/30/2027
- 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
- Recalling firm
- Padagis US LLC
- Quantity
- 180,936 tubes
- Distribution
- USA Nationwide
- Recall date
- July 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)