Drug recall
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis…
FDA recall event 99283 · Class II · Padagis US LLC
Key facts
| Event ID | 99283 |
|---|---|
| Recall numbers | D-0677-2026 |
| Recalling firm | Padagis US LLC |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent Drug: Low out of specification assay results performed during long-term stability testing. |
| Initiation date | Jun 23, 2026 |
| Report date | Jul 22, 2026 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2127022 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: