Lactulose recalls
The FDA has published 9 recalls involving Lactulose since 2016. The latest was reported on 7 Jun 2023. Most were for sterility. VistaPharm has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls9since 2016
Last 12 months0reported
Class I00% of total
Ongoing2latest 7 Jun 2023
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 9 100%Class III 0 0%
Why lactulose is recalled
Companies
By year
Ongoing lactulose recalls
2 active| 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 |
All lactulose recalls, newest first
9 total| 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 |
| Drug | CLASS II | Lactulose Solution, USP, dose cups delivers recalled by VistaPharm | VistaPharm | Mold | 7 states |
| Drug | CLASS II | Lactulose Solution, USP dose cups recalled by VistaPharm | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Lactulose Solution, USP dose cups recalled by VistaPharm | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Lactulose Solution, USP unit dose cups recalled by VistaPharm | VistaPharm | Sterility | Nationwide |
Should you stop taking Lactulose?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.