Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Apr 6, 2011 (16 years ago)

Xactdose Phenytoin Oral Suspension

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50

Affected NDC 66689-0035-50

Compare with the code on your package — it is the most precise check available.

Drug: Phenytoin

Recalling firm
VistaPharm, Inc.
NDC code
66689-035-50
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1658-2012 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Phenytoin recalls

See all
Class I · High risk

Phenytoin Oral Suspension

Failed Content Uniformity Specifications

Terminated Wrong potency / content The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7079-24 D-0153-2024
Class II · Moderate risk

Extended Phenytoin Sodium Capsules

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Terminated Dissolution failure Amneal Pharmaceuticals of New York, LLC NDC 65162-212-10 D-0876-2023
Class III · Low risk

Phenytoin Sodium Injection

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-05 D-0070-2023
Class III · Low risk

Phenytoin Sodium Injection

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-02 D-0069-2023

Other recalls by VistaPharm, Inc.

All 2011 recalls