Nystatin Oral Suspension — Class III drug recall D-0869-2017
Terminated recall by VistaPharm, Inc., reported 2017-06-07, distributed nationwide. Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification
| Recall number | D-0869-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2017-05-17 |
| Classified | 2017-05-31 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2020-01-13 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 66689-0008-02, 66689-0037-01, 66689-0037-50, 66689-0037-99 |
| Lot numbers | 431300, 432500, 434000, 443800, 445500, 460500, 461500, 462200 |
| Expiration dates | 2017-07, 2017-09, 2018-01, 2018-02 |
Product
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Reason for recall
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
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-0869-2017. 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.