Nystatin recalls
Nystatin products have been recalled 6 times, most recently on 22 Jul 2026. The recalling company is usually PAI Holdings. The most common reason is potency & assay.
Total recalls6since 2018
Last 12 months1reported
Class I00% of total
Ongoing1latest 22 Jul 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 5 83%Class III 1 17%
Why nystatin is recalled
Companies
Product types
By year
Ongoing nystatin recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin Cream USP, (100,000 USP Nystatin Units) recalled by Padagis USNystatin | Padagis US | Potency & Assay | Nationwide |
All nystatin recalls, newest first
6 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin Cream USP, (100,000 USP Nystatin Units) recalled by Padagis USNystatin | Padagis US | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL Cherry/Peppermint Flavor recalledNystatin | Pharmaceutical Associates | Potency & Assay | Nationwide |
| Drug | CLASS III | Nystatin Oral Suspension, USP, For Institutional Use Only recalledNystatin | Pharmaceutical Associates | Potency & Assay | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.