Nystatin Topical Powder — Class II drug recall D-1059-2017
Terminated recall by X-Gen Pharmaceuticals Inc., reported 2017-08-16, distributed nationwide. Presence of Foreign Substance: potential presence of plastic particles.
| Recall number | D-1059-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-Gen Pharmaceuticals Inc., Horseheads, NY, United States |
| Recall initiated | 2017-05-17 |
| Classified | 2017-08-09 |
| Reported by FDA | 2017-08-16 |
| Terminated | 2018-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 9,816 bottles |
| NDC | 42543-0052-61 |
| Lot numbers | 23701.158A |
| Expiration dates | 2018-10-31 |
Product
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Reason for recall
Presence of Foreign Substance: potential presence of plastic particles.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1059-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.