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
USNystatin 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
Recalling Firm: Padagis US LLC
Reason for Recall / Hazard
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Minneapolis |
| State | MN |
| Openfda › Nui › 1 | N0000175498 |
| Openfda › Nui › 2 | M0017172 |
| Openfda › Unii | BDF1O1C72E |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 543546 |
| Openfda › Spl id | e2839c50-5b8f-4e7b-9636-d22687038a89 |
| Openfda › Brand name | NYSTATIN |
| Openfda › Spl set id | e630aa3d-11a6-4300-942a-cbdf2d016f77 |
| Openfda › Package ndc › 1 | 45802-059-35 |
| Openfda › Package ndc › 2 | 45802-059-11 |
| Openfda › Product ndc | 45802-059 |
| Openfda › Generic name | NYSTATIN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Polyenes [CS] |
| Openfda › Substance name | NYSTATIN |
| Openfda › Pharm class epc | Polyene Antifungal [EPC] |
| Openfda › Manufacturer name | Padagis Israel Pharmaceuticals Ltd |
| Openfda › Application number | ANDA062225 |
| Openfda › Is original packager | true |
| Event id | 99283 |
| Address 1 | 3940 Quebec Ave N |
| Code info | Lot #: 205060, Exp 09/30/2027 |
| Postal code | 55427-1244 |
| Report date | 20260722 |
| Product type | Drugs |
| Product quantity | 180,936 tubes |
| Reason for recall | Subpotent Drug: Low out of specification assay results performed during long-term stability testing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260623 |
| Initial firm notification | Letter |
| Center classification date | 20260713 |
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmPadagis US LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUSA Nationwide
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Padagis US LLC - 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 Check if your household is affected: https://therecallfile.com/recalls/nystatin-cream-usp-100-000-usp-nystatin-units-net-wt-15-g-rx-only-15-g/FDA-D-0677-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Related Recalls
UKClass 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Class 4 Medicines Defect Notification: Neuraxpharm UK Ltd, Tuzulby prolonged-release chewable tablets, EL(26)A/36
Neuraxpharm UK Ltd has informed the MHRA of missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for certain batches of Tuzulby prolonged r...
FDA Drugsmeijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DrugsCVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).