NYSTATIN ORAL SUSPENSION — Class III drug recall D-0019-2021
Terminated recall by VistaPharm, Inc., reported 2020-10-14, distributed nationwide. Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
| Recall number | D-0019-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2020-09-25 |
| Classified | 2020-10-05 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2022-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 14,244 |
| Reason classes | specification failure |
| NDC | 66689-0008-16 |
| Lot numbers | 10/21, 638800 |
Product
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Reason for recall
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
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-0019-2021. 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.