FDA Drug recall D-913-2013
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc
- FDA Drug
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc by Vistapharm, citing failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-913-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-04 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vistapharm |
| Distribution | US |
Product
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Reason
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Identifiers
| code_info | Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-913-2013%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.