Nystatin recalls
The FDA has published 24 recalls involving Nystatin since 2013. The latest was reported on 22 Jul 2026. Most were for potency & assay. VistaPharm has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 24 since 2013
Last 12 months 1 reported
Class I 0 0% of total
Ongoing 1 latest 22 Jul 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%16 67%8 33%
Ongoing nystatin recalls 1 active
All nystatin recalls, newest first 24 total Reported Class Recall Company Reason Where 22 Jul 2026 Drug CLASS II Nystatin Cream USP, (100,000 USP Nystatin Units) recalled by Padagis US Nystatin Padagis US Potency & Assay Nationwide 30 Mar 2022 Drug CLASS II Nystatin and Triamcinolone Acetonide Ointment recalled Teligent Pharma Potency & Assay Nationwide 18 Aug 2021 Drug CLASS II Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalled Nystatin PAI Holdings Manufacturing (CGMP) Deviations Nationwide 14 Oct 2020 Drug CLASS III Nystatin Oral Suspension, USP per mL Contains recalled by VistaPharm VistaPharm Potency & Assay Nationwide 19 Aug 2020 Drug CLASS II Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalled Nystatin PAI Holdings Potency & Assay Nationwide 15 Jul 2020 Drug CLASS III Nystatin Oral Suspension, USP per mL, Bubblegum Flavored recalled VistaPharm Potency & Assay PR 15 Jul 2020 Drug CLASS III Nystatin Oral Suspension, USP Cup, Delivers recalled by VistaPharm VistaPharm Potency & Assay PR 1 Jul 2020 Drug CLASS II Nystatin Cream, USP per gram recalled by Crown Laboratories Nystatin Cream Crown Laboratories Potency & Assay Nationwide 1 Jul 2020 Drug CLASS II Nystatin Cream, USP per gram recalled by Crown Laboratories Nystatin Cream Crown Laboratories Potency & Assay Nationwide 1 Apr 2020 Drug CLASS II Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalled Nystatin PAI Holdings Potency & Assay Nationwide 5 Feb 2020 Drug CLASS II Nystatin Oral Suspension, USP per mL Cherry/Peppermint Flavor recalled Nystatin Pharmaceutical Associates Potency & Assay Nationwide 31 Jul 2019 Drug CLASS III Nystatin and Triamcinolone Acetonide Cream USP100/g, 0.1% tube recalled Nystatin And Triamcinolone Acetonide Lupin Pharmaceuticals Potency & Assay Nationwide 10 Apr 2019 Drug CLASS III Nystatin Oral Suspension, USP per mL recalled by Akorn Akorn Potency & Assay AR, MS 26 Dec 2018 Drug CLASS III Nystatin Oral Suspension, USP, unit dose cups recalled by VistaPharm VistaPharm Potency & Assay Nationwide 10 Oct 2018 Drug CLASS II Nystatin and Triamcinolone Acetonide Cream, USP/gm & 1 mg/gm recalled Dr. Reddy's Laboratories Potency & Assay Nationwide 13 Jun 2018 Drug CLASS III Nystatin Oral Suspension, USP, For Institutional Use Only recalled Nystatin Pharmaceutical Associates Potency & Assay Nationwide 16 Aug 2017 Drug CLASS II Nystatin Topical Powder, USP, 100,000 USP units per gram recalled X-Gen Pharmaceuticals Particulate Matter Nationwide 7 Jun 2017 Drug CLASS III Nystatin Oral Suspension, USP/mL recalled by VistaPharm VistaPharm Potency & Assay Nationwide 26 Apr 2017 Drug CLASS II Nystatin and Triamcinolone Acetonide Cream recalled Nystatin And Triamcinolone Acetonide Taro Pharmaceuticals U Potency & Assay Nationwide 8 Feb 2017 Drug CLASS II Nystatin Oral Suspension, USP per mL, a) recalled by VistaPharm VistaPharm Sterility Nationwide 8 Feb 2017 Drug CLASS II Nystatin Oral Suspension, USP, a) recalled by VistaPharm VistaPharm Sterility Nationwide 10 Feb 2016 Drug CLASS II Nystatin, USP Powder for Rx compounding, 150 Million Units recalled Perrigo Packaging Defects Nationwide 10 Feb 2016 Drug CLASS II Nystatin, USP Powder for Rx compounding, 50 Million Units recalled Perrigo Packaging Defects Nationwide 28 Aug 2013 Drug CLASS II Nystatin Oral Suspension, USP recalled by VistaPharm VistaPharm Potency & Assay Nationwide
Should you stop taking Nystatin?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.