Padagis recalls 15g Nystatin Cream USP (Rx only) due to low drug potency from stability testing. Consumers should contact manufacturer for details.
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Padagis is recalling 15g Nystatin Cream USP (Rx only) because lab tests showed the medication has lower-than-stated potency. This means the cream may not work as intended for treating fungal infections.
The cream was found to have lower-than-stated potency during long-term stability testing. This means it may not effectively treat fungal infections as intended, but does not pose an immediate safety risk.
Prescription users of Nystatin Cream USP (15g tube) manufactured by Padagis. Patients with fungal infections who require this medication are most at risk.
Look for the 15g tube labeled 'Nystatin Cream USP (100,000 USP Nystatin Units)' manufactured by Padagis in Israel. The product was sold with NDC 45802-059-35 and Lot #205060, expiring September 30, 2027.
Verify the product label matches the recalled Nystatin Cream USP (15g tube) with NDC 45802-059-35 and Lot #205060.
The recall is due to potential lower potency, not safety risks. The cream may not work as intended for fungal infections.
The recall record does not specify a remedy or action for consumers.
The recall record does not mention replacement options or contact information.
We’ve drafted a message you can send Padagis to request your refund or repair — edit it as you like.
Subject: Recall D-0677-2026 — Padagis Padagis Hello, I own a Padagis that is covered by recall D-0677-2026 from Padagis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
