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 |
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.
How to identify the recalled item
| Lot / date codes | Lot #: 205060, Exp 09/30/2027 |
|---|---|
| Lot / date codes | Lot #: 205060, Exp 09/30/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.