CLASS II Drug recall · Reported 30 Nov 2016 · FDA Enforcement Report
Lactulose Solution, USP unit dose cups recalled by VistaPharm
VistaPharm is recalling Lactulose Solution, USP unit dose cups (, distributed nationwide in the US. The recall was initiated on 9 Nov 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0146-2017
- FDA event ID
- 75752
- Recalling firm
- VistaPharm, Largo, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2016
- FDA classified
- 22 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
Timeline
| 9 Nov 2016 | Recall initiated by company | |
| 22 Nov 2016 | Classified by FDA | +13 days |
| 30 Nov 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Which lots are affected?
Lot No. 378300, Exp 11/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from VistaPharm
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Aminocaproic Acid Oral Solution/mL recalled by VistaPharm | VistaPharm | Packaging Defects | Nationwide |
| Drug | CLASS III | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalled | VistaPharm | Other | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Other Bacterial Contamination | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide | VistaPharm | Potency & Assay | Nationwide |
Other Lactulose recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lactulose Solution, USP (Oral) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lactulose Solution, USP (For oral or rectal administration) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lactulose Solution, USP, For Oral Administration recalled | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS II | Lactulose Solution, USP, For Oral or Rectal Administration recalled | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS II | Lactulose Solution, USP, dose cups delivers packaged dose cups recalled | VistaPharm | Mold | 7 states |