Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Phenytoin Oral Suspension USP 125mg/5mL Recalled by VistaPharm, Inc. Due to Defective Container: A lidding deformity allowed for the...

Date: October 15, 2013
Company: VistaPharm, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact VistaPharm, Inc. directly.

Affected Products

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

Quantity: 27,788 cases

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About VistaPharm, Inc.

VistaPharm, Inc. has 32 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report