Nystatin Oral Suspension — Class II drug recall D-0457-2017
Terminated recall by VistaPharm, Inc., reported 2017-02-08, distributed nationwide. CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkhold
| Recall number | D-0457-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2017-01-18 |
| Classified | 2017-02-02 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2021-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 67,955 bottles |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| NDC | 66689-0008-02, 66689-0008-16 |
| Lot numbers | 422600, 424200 |
Product
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Reason for recall
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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-0457-2017. 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.