Why was lactulose recalled?: The 2016 VistaPharm Microbial Contamination

October 7, 2025 •

2 min read

In 2016, a Class II recall was issued for nearly 1,500 cases of Lactulose Solution, USP, by its manufacturer, VistaPharm, Inc.. This action addressed the question of why was lactulose recalled, specifically citing microbial contamination. The contamination involved the presence of Burkholderia cepacia bacteria in the bulk solution.

Quick Summary

A 2016 lactulose recall by VistaPharm was due to microbial contamination with Burkholderia cepacia. The Class II recall affected 1,500 cases of Lactulose Solution nationwide.

Key Points

Cause of the Recall: The recall was initiated due to microbial contamination of the bulk lactulose solution with Burkholderia cepacia bacteria.
Manufacturer and Date: VistaPharm, Inc. voluntarily initiated the recall on November 9, 2016.
Recall Classification: The FDA classified the event as a Class II recall. {Link: HMP Global Learning Network https://www.hmpgloballearningnetwork.com/site/pln/content/lactulose-solution-recalled}
Affected Product: The recall specifically impacted Lactulose Solution, USP, 10 g/15 mL, in 15-mL unit dose cups.
Health Risks: While the risk to the general public was low, Burkholderia cepacia poses a more significant threat to immunocompromised individuals.
Recall Action: The manufacturer removed nearly 1,500 cases of the contaminated product from distribution.
Patient Advice: Consumers were advised to check lot numbers and discard affected products, and to contact a healthcare provider with concerns.

The 2016 Lactulose Recall: A Microbial Contamination Issue

The reason behind the specific lactulose recall in 2016 was a confirmed microbial contamination. VistaPharm, Inc. initiated a voluntary, Class II recall of its Lactulose Solution, USP, because the bulk solution tested positive for Burkholderia cepacia bacteria.

Understanding the Recall Classification

The FDA classified this as a Class II recall. {Link: HMP Global Learning Network https://www.hmpgloballearningnetwork.com/site/pln/content/lactulose-solution-recalled}

The Threat of Burkholderia cepacia

Burkholderia cepacia is a group of bacteria often resistant to antibiotics. While generally harmless to healthy individuals, it can cause severe, potentially life-threatening infections in vulnerable populations like those with compromised immune systems or cystic fibrosis. The contamination posed a risk, especially for patients taking lactulose for conditions like hepatic encephalopathy, highlighting the importance of quality control even for non-sterile products.

Key Details of the VistaPharm Lactulose Recall

{Link: HMP Global Learning Network https://www.hmpgloballearningnetwork.com/site/pln/content/lactulose-solution-recalled}.

How to identify the recalled product

Consumers and healthcare providers could identify the recalled product by its lot number and expiration date. Affected individuals were advised to contact their doctor or pharmacist and properly dispose of the product.

Comparison with a more recent laxative recall

Here is a comparison between the 2016 lactulose recall and a 2022 recall of magnesium citrate saline laxative:


Feature	VistaPharm Lactulose Recall (2016)	Vi-Jon Magnesium Citrate Saline Laxative Recall (2022)
Manufacturer	VistaPharm, Inc.	Vi-Jon LLC
Reason for Recall	Microbial contamination with Burkholderia cepacia	Microbial contamination with Gluconacetobacter liquefaciens
Recall Classification	Class II	Initiated voluntarily, FDA confirmed concern
Affected Product	Lactulose Solution, USP	Magnesium Citrate Saline Laxative Oral Solution (all flavors)
Risk Profile	Temporary or reversible adverse health consequences; remote probability of serious harm	Increased risk of serious, life-threatening infections, especially for immunocompromised patients
Timeline	Initiated in November 2016	Initiated in July 2022

This comparison highlights that different microbial contaminants can lead to recalls with varying levels of potential risk to patients.

The importance of FDA regulations and pharmacovigilance

Drug recalls like the 2016 lactulose event underscore the critical role of FDA regulations and pharmacovigilance in ensuring medication safety. Manufacturers must adhere to strict quality control, while consumers should stay informed about health notices and consult healthcare providers with concerns. The reporting of adverse events by healthcare professionals is also vital for maintaining a safe drug supply.

Conclusion

The 2016 lactulose recall by VistaPharm, Inc. was due to microbial contamination with Burkholderia cepacia. This Class II recall by the FDA highlighted risks for vulnerable individuals and emphasizes the need for stringent quality control in pharmaceutical manufacturing. For more information on past and current recalls, visit the FDA Enforcement Report database.

Frequently Asked Questions

The recall was initiated by VistaPharm, Inc., the manufacturer of the Lactulose Solution, USP, that was found to be contaminated.

No, the specific lactulose recall related to microbial contamination occurred in late 2016.

Burkholderia cepacia is a group of bacteria that can cause infections, particularly in people with weakened immune systems or chronic lung diseases like cystic fibrosis. It is often resistant to many common antibiotics.

A Class II recall is for a situation where using or being exposed to the contaminated product might cause temporary or medically reversible adverse health consequences, but the chance of serious consequences is remote.

If you possess any of the affected product, you should not use it. Check the lot number and expiration date to confirm. You should contact your healthcare provider or pharmacist for guidance.

No, this recall was specific to a single lot manufactured by VistaPharm, Inc. in 2016. Other lactulose products from different manufacturers are not affected.

The initial FDA report classified the recall based on the potential risk, noting the probability of serious adverse consequences was remote. Information on specific reported adverse events is not detailed in the recall summary.

You can monitor the FDA website, specifically their Enforcement Report database, and subscribe to their safety alerts to stay informed about product recalls.