VistaPharm Lactulose Solution Recall: Microbial Contamination Risk
VistaPharm recalls Lactulose Solution (10g/15mL) due to Burkholderia cepacia contamination. This non-sterile product poses infection risks if used improperly. Check NDC 66689-039-01 or 66689-039-50 for affected units.
Lower-risk recall
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Contact the company
What happened, in plain English
VistaPharm is recalling Lactulose Solution 10g/15mL unit dose cups because they were contaminated with Burkholderia cepacia bacteria. Using this product could lead to infections, especially since it's a non-sterile medication. Read more at govinfonow.com/recall/42256-vistapharm-lactulose-solution-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42256-vistapharm-lactulose-solution-recall-microbial-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0146-2017
Cite this page
“VistaPharm Lactulose Solution Recall: Microbial Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42256-vistapharm-lactulose-solution-recall-microbial-contamination-risk. Based on FDA recall #D-0146-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0146-2017%22&limit=1).
Why it’s dangerous
The product was tested and found to contain Burkholderia cepacia bacteria, a type of bacteria that can cause infections. Since this is a non-sterile medication, contamination could lead to health issues if the product is used without proper sterilization.
Who’s affected
People who have prescription Lactulose Solution 10g/15mL in 15mL x 50-unit dose cups (NDC 66689-039-01 or 66689-039-50) are affected. Those with medical conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the product name 'Lactulose Solution, USP, 10 g/15 mL' in 15 mL unit dose cups (NDC 66689-039-01) or 15 mL x 50 unit dose cups per case (NDC 66689-039-50). The product is prescription-only and manufactured by VistaPharm, Inc.
- Brand
VistaPharm- Category
Drug
What to do — step by step
Check Product Details
Look for NDC codes 66689-039-01 or 66689-039-50 on the packaging to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0146-2017 (November 9, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0146-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.