Use cautionDrug recall · FDA · Published April 6, 2011
VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Defective Containers
VistaPharm recalls specific lots of Xactdose Phenytoin Oral Suspension because defective containers allow moisture loss, potentially altering the drug's viscosity and assay.
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
VistaPharm, Inc. is recalling Xactdose Phenytoin Oral Suspension, USP, 125mg/5 mL supplied in 5 mL unit dose cups due to defective containers. The lidding deformity allows the product to transpire, leading to moisture loss that can cause viscosity and assay failures. This recall affects nationwide distribution. Read more at govinfonow.com/recall/48988-vistapharm-inc-recalls-xactdose-phenytoin-oral-suspension-usp-125mg-5.
“VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Defective Containers.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48988-vistapharm-inc-recalls-xactdose-phenytoin-oral-suspension-usp-125mg-5. Based on FDA recall #D-1658-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1658-2012%22&limit=1).
The FDA announced on April 6, 2011, that VistaPharm, Inc. voluntarily recalled Xactdose Phenytoin Oral Suspension due to defective containers causing potential viscosity and assay failures. The recall affects products distributed nationwide.
How to tell if you have it
Brand: VistaPharm
Product: Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL
Packaging: 5 mL unit dose cups
NDC: 66689-035-50
Lot code: 202800
The hazard
The defective container's lidding deformity allows the product to transpire, leading to moisture loss. This moisture loss causes the viscosity and assay levels to increase relative to the sample volume.
Context
GovInfoNow's records show VistaPharm, Inc. has had 19 other recalls since January 19, 2011. Recent similar recalls include a Pyridostigmine Bromide Oral Solution recall for preservative issues on September 30, 2022, and a Clobazam Oral Suspension recall for failed stability specifications on January 7, 2022. Other recent recalls of similar products include an Estradiol Gel recall due to defective containers (May 12, 2026), a Diclofenac Gel recall for failed viscosity specifications (January 27, 2026), and a Desmopressin Nasal Spray recall for defective bottle caps risk (April 8, 2026).
How to tell if you have this one
Check for Xactdose Phenytoin Oral Suspension, USP, 125mg/5 mL in 5 mL unit dose cups manufactured by VistaPharm, Inc. Look for NDC 66689-035-50 and Lot number 202800.
Brand
VistaPharm
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Verify if your Xactdose Phenytoin Oral Suspension matches the recalled NDC 66689-035-50 and Lot 202800.
Contact Your Provider
Consult your healthcare provider or pharmacist regarding the defect and potential replacement options.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1658-2012 (April 6, 2011) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1658-2012 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.