Nystatin Cream USP recall (Padagis US LLC)
DrugClass IIOngoing
Summary: Padagis US LLC is recalling 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.
What is being recalled
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
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot #: 205060, Exp 09/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0677-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 23, 2026 |
| Reported | July 22, 2026 |
| Company | Padagis US LLC |
| Company location | Minneapolis, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 180,936 tubes |
More recalls from Padagis US LLC · all drug recalls · recalls from June 2026