Use caution Drug recall · FDA · Published September 30, 2011

VistaPharm Recalls Xactdose Phenytoin Due to Defective Containers

VistaPharm recalls 27,221 unit dose cups of Xactdose Phenytoin Oral Suspension due to defective containers that may cause product degradation.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1440-2012Drug VistaPharm ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmVistaPharm, Inc.7265 Ulmerton Rd · Largo, FL 33771-4809

✎ GovInfoNow plain-language explainer

VistaPharm, Inc. is recalling Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups. The recall affects specific lots distributed nationwide. The issue stems from defective containers with lidding deformities that allow the product to lose moisture. Read more at govinfonow.com/recall/48965-vistapharm-inc-recalls-xactdose-phenytoin-oral-suspension-usp-125-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/48965-vistapharm-inc-recalls-xactdose-phenytoin-oral-suspension-usp-125-mg · Updated October 13, 2026 · FDA enforcement record: FDA #D-1440-2012

Cite this page

“VistaPharm Recalls Xactdose Phenytoin Due to Defective Containers.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48965-vistapharm-inc-recalls-xactdose-phenytoin-oral-suspension-usp-125-mg. Based on FDA recall #D-1440-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1440-2012%22&limit=1).

The FDA announced on September 30, 2011, that VistaPharm, Inc. voluntarily recalled Xactdose Phenytoin Oral Suspension due to defective containers that may cause viscosity and assay failures. The agency issued recall number D-1440-2012 for the Class II recall.

How to tell if you have it

Brand: VistaPharm
Product: Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL
Packaging: 5 mL unit dose cups
NDC: 66689-036-50
Lot codes: 210900, 214000, 220100, 224800, 228700, 232800
Distribution: Nationwide
Units affected: 27,221 unit dose cups

The hazard

The defective container 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 on record since January 19, 2011. Other recent recalls of similar products include ANI Pharmaceuticals Estradiol Gel recall (May 12, 2026), Apotex Desmopressin Nasal Spray recall (April 8, 2026), and Sun Pharmaceutical Diclofenac Gel recall (January 27, 2026).

How to tell if you have this one

Check if you have Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL in 5 mL unit dose cups manufactured by VistaPharm. Look for NDC 66689-036-50 and lot numbers 210900, 214000, 220100, 224800, 228700, or 232800.

Brand
VistaPharm
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Lot Numbers
Verify if your unit dose cups match the recalled NDC 66689-036-50 and lot numbers 210900, 214000, 220100, 224800, 228700, or 232800.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

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 2.2 years after the firm started it.

Sep 30, 2011Firm started the recall
Aug 2, 2012FDA classified it Class II
Aug 8, 2012Published in FDA’s Enforcement Report
Dec 12, 2013FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/48965-vistapharm-inc-recalls-xactdose-phenytoin-oral-suspension-usp-125-mg">VistaPharm Recalls Xactdose Phenytoin Due to Defective Containers (GovInfoNow)</a>

Where this comes from

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-1440-2012 (September 30, 2011) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1440-2012 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.