FDA Drug recall D-1378-2020
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manuf…
- FDA Drug
- Class III
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class III recall of Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manuf… by Vistapharm, citing failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1378-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-06-23 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vistapharm |
| Distribution | PR |
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
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Identifiers
| code_info | Lot # 639000, Exp. 10/31/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1378-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.