Use caution Drug recall · FDA · Published October 15, 2013

VistaPharm Phenytoin Recall: Defective Container Hazard

VistaPharm recalls Phenytoin Oral Suspension due to defective containers causing out-of-specification assay and viscosity. Check your lot numbers immediately.

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

🇺🇸 FDA recall #D-342-2014Drug VistaPharm ›

Use caution until it’s fixed

Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

VistaPharm, Inc. is recalling Phenytoin Oral Suspension USP 125mg/5mL because the container lids may be deformed. This defect can cause the medication to have incorrect strength (assay) or thickness (viscosity). The recall affects 27,788 cases distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/46553-vistapharm-inc-recalls-phenytoin-oral-suspension-usp-125mg-5ml-50.

Source Summary by GovInfoNow · govinfonow.com/recall/46553-vistapharm-inc-recalls-phenytoin-oral-suspension-usp-125mg-5ml-50 · Updated October 13, 2026 · FDA enforcement record: FDA #D-342-2014

Cite this page

“VistaPharm Phenytoin Recall: Defective Container Hazard.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46553-vistapharm-inc-recalls-phenytoin-oral-suspension-usp-125mg-5ml-50. Based on FDA recall #D-342-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-342-2014%22&limit=1).

VistaPharm, Inc. voluntarily recalled Phenytoin Oral Suspension USP 125mg/5mL on Oct. 15, 2013, after the FDA announced the product had defective containers causing out-of-specification assay and viscosity results. The recall affects 27,788 cases distributed nationwide and in Puerto Rico.

How to tell if you have it

Brand: VistaPharm
Product: Phenytoin Oral Suspension USP 125mg/5mL
NDC: 66689-036-50
Lots: 268200 (Exp 06/14), 274600 (Exp 08/14), 279500 (Exp 09/14), 290700 (Exp 12/14), 296700 (Exp 02/15), 305100 (Exp 06/15)
Quantity: 50 cups per case
Distribution: Nationwide and Puerto Rico

The hazard

The FDA said the recall is due to a lidding deformity in the containers that allowed for out-of-specification results for assay and viscosity at the 12-month stability timepoint.

Context

GovInfoNow's records show VistaPharm, Inc. has had 19 other recalls on record since Jan. 19, 2011. Other recent recalls of similar products include a Pyridostigmine Bromide Oral Solution recall for preservative issues (Sept. 30, 2022), a Clobazam Oral Suspension recall for failed stability specifications (Jan. 7, 2022), and a Nystatin Oral Suspension recall for impurity risk (Sept. 25, 2020).

How to tell if you have this one

Look for Phenytoin Oral Suspension USP 125mg/5mL manufactured by VistaPharm, Inc. of Largo, FL (NDC 66689-036-50). Check the expiration dates and lot numbers on the label: Lot 268200 (Exp 06/14), Lot 274600 (Exp 08/14), Lot 279500 (Exp 09/14), Lot 290700 (Exp 12/14), Lot 296700 (Exp 02/15), and Lot 305100 (Exp 06/15).

Brand
VistaPharm
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Phenytoin Oral Suspension matches the affected lot numbers and expiration dates listed in the recall.
Contact Your Pharmacist
Inform your pharmacist or healthcare provider that you have one of the recalled lots so they can assist with replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

Oct 15, 2013Firm started the recall
Dec 6, 2013FDA classified it Class II
Dec 18, 2013Published in FDA’s Enforcement Report
Sep 28, 2016FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/46553-vistapharm-inc-recalls-phenytoin-oral-suspension-usp-125mg-5ml-50">VistaPharm Phenytoin Recall: Defective Container Hazard (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-342-2014 (October 15, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-342-2014 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.