NYSTATIN Oral Suspension — Class III drug recall D-0348-2019
Terminated recall by VistaPharm, Inc., reported 2018-12-26, distributed nationwide. Failed Impurities/Degradation Specifications:Out of specification for impurities.
| Recall number | D-0348-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2018-11-30 |
| Classified | 2019-01-07 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-11-25 |
| Distributed | Nationwide (US) |
| Quantity | 4,065,550 |
| Reason classes | specification failure |
| NDC | 66689-0037-50, 66689-0037-99 |
| Expiration dates | 2018-12-20, 2019-04-20, 2019-07-20, 2019-08-20, 2019-09-20, 2019-10-20 |
Product
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Reason for recall
Failed Impurities/Degradation Specifications:Out of specification for impurities.
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-0348-2019. 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.