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.

Lactulose Solution Recalled by VistaPharm, Inc. Due to CGMP Deviations: Purified water used to manufacture the...

Date: January 18, 2017
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

Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.

Quantity: 18,437 unit dose cups

Why Was This Recalled?

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

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