CLASS II Drug recall · Reported 16 Aug 2017 · FDA Enforcement Report
Nystatin Topical Powder, USP, 100,000 USP units per gram recalled
X-Gen Pharmaceuticals is recalling Nystatin Topical Powder, USP, 100,000 USP units per gram per, distributed nationwide in the US. The recall was initiated on 17 May 2017 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-1059-2017
- FDA event ID
- 77834
- Recalling firm
- X-Gen Pharmaceuticals, Horseheads, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2017
- FDA classified
- 9 Aug 2017
- Reported
- 16 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 May 2017 | Recall initiated by company | |
| 9 Aug 2017 | Classified by FDA | +84 days |
| 16 Aug 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: potential presence of plastic particles.
Product as listed by the FDA
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: potential presence of plastic particles.
Which lots are affected?
Lot #: 23701.158A, EXP 10/31/18
Where was it sold?
Nationwide in the US
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.
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Other Nystatin recalls
All 24| 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 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 |