CLASS II ONGOING Drug recall · Reported 22 Jul 2026 · FDA Enforcement Report
Nystatin Cream USP, (100,000 USP Nystatin Units) recalled by Padagis US
Padagis US is recalling Nystatin Cream USP, (100,000 USP Nystatin Units), distributed nationwide in the US. The recall was initiated on 23 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0677-2026
- FDA event ID
- 99283
- Recalling firm
- Padagis US, Minneapolis, MN
- Brand
- Nystatin
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jun 2026
- FDA classified
- 13 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 Jun 2026 | Recall initiated by company | |
| 13 Jul 2026 | Classified by FDA | +20 days |
| 22 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Which lots are affected?
Lot #: 205060, Exp 09/30/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Padagis US
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets recalled by Padagis US | Padagis US | Packaging Defects | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Padagis US | Padagis US | Potency & Assay | Nationwide |
| Drug | CLASS II | Trospium Chloride Extended-Release Capsules, 60 mg recalledTrospium Chloride | Padagis US | Other | Nationwide |
| Drug | CLASS II | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream recalled by Padagis USGynazole 1 | Padagis US | Packaging Defects | Nationwide |
| Drug | CLASS III | Evamist (estradiol transdermal spray) recalled by Padagis USEvamist | Padagis US | Potency & Assay | Nationwide |
Other Nystatin recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin and Triamcinolone Acetonide Ointment recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Nystatin Oral Suspension, USP per mL Contains recalled by VistaPharm | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Potency & Assay | Nationwide |
| Drug | CLASS III | Nystatin Oral Suspension, USP per mL, Bubblegum Flavored recalled | VistaPharm | Potency & Assay | PR |