Nystatin Oral Suspension — Class III drug recall D-1378-2020
Terminated recall by VistaPharm, Inc., reported 2020-07-15, distributed in PR. Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
| Recall number | D-1378-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2020-06-23 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2022-09-28 |
| Distributed | PR |
| Quantity | 14,760 bottles |
| Reason classes | specification failure |
| NDC | 66689-0008-16 |
| Lot numbers | 639000 |
| Expiration dates | 2021-10-31 |
Product
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Reason for recall
Failed impurities/degradation products; Presence of an impurity peak that exceeds the 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-1378-2020. 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.