Ioversol recalls

The FDA has published 2 recalls involving Ioversol since 2019. The latest was reported on 19 Aug 2026. Most were for packaging defects. Liebel-Flarsheim 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 2019

Last 12 months1reported

Class I150% of total

Ongoing1latest 19 Aug 2026

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

Severity split

Class I 1 50%Class II 1 50%Class III 0 0%

Why ioversol is recalled

Packaging Defects150%
Particulate Matter150%

Companies

Liebel-Flarsheim150%
Guerbet150%

By year

2026150%
2019150%

Ongoing ioversol recalls

1 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS I	Optiray Imaging -350, Ioversol Injection recalledOptiray	Liebel-Flarsheim	Particulate Matter	Nationwide

All ioversol recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS I	Optiray Imaging -350, Ioversol Injection recalledOptiray	Liebel-Flarsheim	Particulate Matter	Nationwide
16 Oct 2019Drug	CLASS II	Optiray 320 (ioversol) Injection recalled by GuerbetOptiray	Guerbet	Packaging Defects	Nationwide

Should you stop taking Ioversol?

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.