Quick Facts at a Glance
- Recall Date
- June 23, 2026
- Hazard Level
- HIGH
- Brands
- NYSTATIN, Padagis Israel Pharmaceuticals Ltd
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- NYSTATIN, Padagis Israel Pharmaceuticals Ltd
- Model numbers
- Lot #: 205060, Exp 09/30/2027
- UPC codes
- 45802-059, 45802-059-35, 45802-059-11
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 23, 2026
Reported by FDA DRUG
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Padagis US LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
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. Generic: NYSTATIN; Brand: NYSTATIN. Reason: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.. Classification: Class II. Quantity: 180,936 tubes. Distribution: USA Nationwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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