Padagis US LLC Nystatin Cream USP Recall
Announced 2026-07-22 · FDA
Padagis US LLC recalls Nystatin Cream USP (100,000 USP Nystatin Units) in a 15 g tube (Lot 205060) due to subpotent drug results detected during long-term stability testing. The affected product was distributed nationwide in the USA and has expiration date 09/30/2027. The recall is conducted under FDA oversight.
| Brand | Padagis US LLC |
|---|---|
| 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 | Subpotent Drug: Low out of specification assay results performed during long-term stability testing. |
| Severity | moderate |
| Units affected | 180936 |
| Distribution | USA Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot #: 205060, Exp 09/30/2027 |
WHAT YOU SHOULD DO
- Do not use any product from Lot 205060; set aside the tube(s).
- Do not dispose of the product yourself; follow recall instructions for return, disposal, or exchange.
- Contact Padagis US LLC or your pharmacist/healthcare provider for guidance and potential replacement.
- Check the FDA recall notices or Padagis website for updates and additional instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.