Pentosan Polysulfate recalls
The FDA has published 2 recalls involving Pentosan Polysulfate since 2020. The latest was reported on 20 Jul 2022. Most were for sterility. TMC Acquisition 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 recalls2since 2020
Last 12 months0reported
Class I00% of total
Ongoing2latest 20 Jul 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why pentosan polysulfate is recalled
Companies
By year
Ongoing pentosan polysulfate recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pentosan Polysulfate Sodium 250mg/mL-vial, Room Temperature recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Pentosan Polysulfate, 300 MG/ML vial recalled by Advanced Nutriceuticals | Advanced Nutriceuticals | Sterility | 7 states |
All pentosan polysulfate recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pentosan Polysulfate Sodium 250mg/mL-vial, Room Temperature recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Pentosan Polysulfate, 300 MG/ML vial recalled by Advanced Nutriceuticals | Advanced Nutriceuticals | Sterility | 7 states |
Should you stop taking Pentosan Polysulfate?
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.