FDAFDA recall D-0677-2026 · Jul 22, 2026
Padagis US LLC: Nystatin Cream USP recall
Recall found
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
Reason for recall
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 205060, Exp 09/30/2027
- Quantity
- 180,936 tubes
- Distribution
- USA Nationwide
- Recalling firm
- Padagis US LLC, Minneapolis, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-23
Source: openFDA enforcement record D-0677-2026 · search recall number D-0677-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.