VistaPharm Lactulose Solution Recall: Microbial Contamination Risk
VistaPharm recalls Lactulose Solution due to microbial contamination. Product failed yeast/mold count tests. Affected units have specific NDC and lot numbers. No remedy stated in recall notice.
Recall notice
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Contact the company
What happened, in plain English
VistaPharm is recalling Lactulose Solution (10g/15mL) because it was contaminated with yeast and mold. This could cause infections if used improperly. The recall affects specific batch numbers and expiration dates. Read more at govinfonow.com/recall/41526-vistapharm-lactulose-solution-recall-microbial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41526-vistapharm-lactulose-solution-recall-microbial-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-1052-2017
Cite this page
“VistaPharm Lactulose Solution Recall: Microbial Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41526-vistapharm-lactulose-solution-recall-microbial-contamination-risk. Based on FDA recall #D-1052-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1052-2017%22&limit=1).
Why it’s dangerous
The product failed yeast and mold count tests, meaning it contains harmful microorganisms. This contamination could lead to infections if the solution is ingested without proper cleaning. The risk increases if the product is not stored or handled correctly.
Who’s affected
People using Lactulose Solution for medical purposes, especially those with weakened immune systems. The risk is higher for individuals who use the product without proper hygiene.
How to tell if you have this one
Check for NDC 66689-038-50 with lot numbers 468300 (exp 09/2018) or 474400 (exp 11/2018). The product comes in 50-unit dose cups per case.
- Brand
VistaPharm- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
CA, IL, LA, NH, OH, PA, SC
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1052-2017 | Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50; Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018 | 6150 cases |
| D-1053-2017 | Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01; Lot #: 458300, Exp 09/2018; 462600, Exp 07/2018; 471000, Exp 10/2018; 474300, Exp 11/2018 | 9945 cases |
What to do — step by step
Check Product Details
Look for NDC 66689-038-50 and lot numbers 468300 or 474400 on the packaging.
Where it went and when
Where it was distributed
Distributed in 7 states.
FDA distribution: “CA, IL, LA, NH, OH, PA, SC” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Louisiana, New Hampshire, Ohio, Pennsylvania, South Carolina.
Recall timeline
FDA terminated this recall 21 months 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-1052-2017 (June 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1052-2017 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.