FDA Drug recall D-0019-2021
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: Vis…
- FDA Drug
- Class III
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class III recall of NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: Vis… by Vistapharm, citing failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0019-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-09-25 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vistapharm |
| Distribution | US |
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
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Identifiers
| code_info | Lots: 638800 Exp 10/21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class III · 2023-11-15 · Vistapharm - Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPh…
FDA Drug · Class I · 2023-10-25 · Vistapharm - Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm,…
FDA Drug · Class II · 2023-09-20 · Vistapharm - Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689…
FDA Drug · Class II · 2022-11-02 · Vistapharm
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0019-2021%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.