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
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
- Agency
- FDA Drug
- Recall date
- Jun 23, 2026
- Status
- Ongoing
- Company
- Padagis US LLC
1. What product was 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
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
Quantity: 180,936 tubes
Code or lot text: Lot #: 205060, Exp 09/30/2027
- LOT
- Exp 09/30/2027
- LOT
- Lot #: 205060
- NDC
- 45802-059
- NDC
- 45802-059-11
- NDC
- 45802-059-35
- RECALL-NUMBER
- D-0677-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- unchanged
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.