VistaPharm Lactulose Solution Recall: FDA Class II

Why it was recalled

Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.

Product description

Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.

Lot numbers, UPCs & expiration codes

Lot No. 378300, Exp 11/16

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0146-2017
Classification: Class II
Status: Terminated
Recall initiated: Nov 9, 2016
FDA report date: Nov 30, 2016
Quantity: 1497 cases
Recall type: Voluntary: Firm initiated
Recalling firm: VistaPharm, Inc.

Original FDA data

Every field from FDA enforcement report D-0146-2017, exactly as published.

Show all FDA fields

City: Largo
State: FL
Status: Terminated
Country: United States
Event ID: 75752
Address: 7265 Ulmerton Rd
Code information: Lot No. 378300, Exp 11/16
Postal code: 33771-4809
Report date: Nov 30, 2016
Product type: Drugs
Recall number: D-0146-2017
Classification: Class II
Recalling firm: VistaPharm, Inc.
Product quantity: 1497 cases
Termination date: Sep 24, 2021
Reason for recall: Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Distribution pattern: Nationwide
Recall initiation date: Nov 9, 2016
Initial firm notification: E-Mail
Center classification date: Nov 22, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0146-2017, published Nov 30, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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VistaPharm Lactulose Solution Recall

Summary