Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Oct 15, 2013 (13 years ago)

Phenytoin Oral Suspension USP 125mg/5mL

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

Why it was recalled

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

Cause type: Packaging defect

Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.

What was recalled

Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

Affected NDC 66689-0036-50

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

Drug: Phenytoin

Recalling firm
VistaPharm, Inc.
NDC code
66689-036-50
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-342-2014 · 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 2013 recalls