Optiray Imaging Bulk Package-350, Ioversol Injection 74%
Recalled by Liebel-Flarsheim Company LLC
Class I — most serious
There is a reasonable chance that using this product could cause serious health problems or death.
Liebel-Flarsheim Company LLC has recalled Optiray Imaging Bulk Package-350, Ioversol Injection 74%, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on August 19, 2026 and was initiated on July 31, 2026. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Optiray Imaging Bulk Package-350, Ioversol Injection 74%, with approximately 3,486 500mL-vials affected. The company behind the recall is Liebel-Flarsheim Company LLC, based in Raleigh, NC. The FDA describes the product as: “Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.”
Why was Optiray Imaging Bulk Package-350, Ioversol Injection 74% recalled?
According to the FDA, the stated reason for the recall is: “Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.” In plain terms, this recall relates to foreign material.
A foreign material recall means that pieces of something which should not be in food — such as metal, plastic, or glass — may be present. These can pose a choking hazard or cause injury. Recalls like these are issued to remove the affected product before anyone is hurt.
What should you do?
If you think you may have bought Optiray Imaging Bulk Package-350, Ioversol Injection 74%, compare it against the product description and identifying codes (Lot # 25ZF3670, Exp Date: May 31, 2027.) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Liebel-Flarsheim Company LLC or your local health authority.
About this recall
This recall was distributed in NC. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Optiray Imaging Bulk Package-350, Ioversol Injection 74%. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: Distributed Nationwide in the US and Mexico..
What foreign material actually means
A foreign material recall means that pieces of something which should not be in food — such as metal, plastic, or glass — may be present. These can pose a choking hazard or cause injury. Recalls like these are issued to remove the affected product before anyone is hurt.
In this case, the concern applies specifically to Optiray Imaging Bulk Package-350, Ioversol Injection 74% from Liebel-Flarsheim Company LLC — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot # 25ZF3670, Exp Date: May 31, 2027.
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- August 19, 2026
- Recall started
- July 31, 2026
- Distributed in
- NC
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Optiray Imaging Bulk Package-350, Ioversol Injection 74% recalled?+
According to the FDA: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless st…
How serious is this recall?+
Class I — most serious. There is a reasonable chance that using this product could cause serious health problems or death.
What should I do if I have Optiray Imaging Bulk Package-350, Ioversol Injection 74%?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0773-2026. Information last synced from the FDA on August 25, 2026.