Pentosan recalls

The FDA has published 2 recalls involving Pentosan since 2013. The latest was reported on 15 Oct 2025. Most were for sterility. GenoGenix 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 2013

Last 12 months1reported

Class I00% of total

Ongoing2latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why pentosan is recalled

Sterility2100%

Companies

GenoGenix150%
Lowlite Investments150%

By year

2025150%
2013150%

Ongoing pentosan recalls

2 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Pentosan for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Pentosan 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All pentosan recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Pentosan for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Pentosan 250 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

Should you stop taking Pentosan?

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.