Xactdose Phenytoin Oral Suspension — Class II drug recall D-1440-2012
Terminated recall by VistaPharm, Inc., reported 2012-08-08, distributed nationwide. Defective container; lidding deformity allows the contained product to transpire causing potential viscosity a
| Recall number | D-1440-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2011-09-30 |
| Classified | 2012-08-02 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 27,221 units |
| Reason classes | potency, packaging |
| NDC | 66689-0036-50 |
| Lot numbers | 210900, 214000, 220100, 224800, 228700, 232800 |
Product
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Reason for recall
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
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-1440-2012. 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.