Phenytoin Oral Suspension USP 125mg/5mL — Class II drug recall D-342-2014
Terminated recall by VistaPharm, Inc., reported 2013-12-18, distributed nationwide. Defective Container: A lidding deformity allowed for the product to have out of specification results for assa
| Recall number | D-342-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2013-10-15 |
| Classified | 2013-12-06 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2016-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 27,788 cases |
| Reason classes | potency, specification failure, packaging |
| NDC | 66689-0036-50 |
| Lot numbers | 02/15, 06/14, 06/15, 08/14, 09/14, 12/14, 268200, 274600, 279500, 290700, 296700, 305100 |
Product
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
Reason for recall
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
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-342-2014. 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.