Nystatin Cream USP — Class II drug recall D-0677-2026
Ongoing recall by Padagis US LLC, reported 2026-07-22, distributed nationwide. Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
| Recall number | D-0677-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Padagis US LLC, Minneapolis, MN, United States |
| Recall initiated | 2026-06-23 |
| Classified | 2026-07-13 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 180,936 tubes |
| Reason classes | potency, specification failure |
| NDC | 45802-0059, 45802-0059-11, 45802-0059-35 |
| Lot numbers | 205060 |
| Expiration dates | 2027-09-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0677-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.