Nystatin Oral Suspension — Class II drug recall D-913-2013
Terminated recall by VistaPharm, Inc., reported 2013-08-28, distributed nationwide. Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
| Recall number | D-913-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2013-07-04 |
| Classified | 2013-08-21 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,707,050 cups |
| Reason classes | specification failure |
| NDC | 66689-0037-01 |
| Lot numbers | 06/13, 240200, 243000, 244800, 245600, 250800, 253600 |
Product
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Reason for recall
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
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-913-2013. 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.