---
title: "OPTIRAY: OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Inje... — FDA announcement Aug 4, 2026 | Is It on Recall"
description: "Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass"
url: https://isitonrecall.com/recall/fdapress-9174cf9d51f12f45-optiray-optiray-imaging-bulk-package-ibp-350-500ml-in-vial-ioversol-injection-74-350-mg-iodine-ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# OPTIRAY: OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml) — FDA announcement Aug 4, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
- **Reason**: Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
- **Classification**: Not supplied
- **Recalling firm**: Liebel-Flarsheim Company, LLC
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: 9174cf9d51f12f45

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/liebel-flarsheim-company-llc-issues-recall-optiray-imaging-bulk-package-350-500ml-vial-nationwide)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | FOR IMMEDIATE RELEASE – July 31, 2026 – Raleigh, North Carolina, Liebel-Flarsheim Company, LLC, is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) for intra-arterial or intra-venous use to the user level (hospitals, imaging centers, healthcare facilities and clinics, and other potential users of the product) due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass.; Liebel-Flarsheim Company, LLC, is notifying its distributors and customers by email and is arranging for return and replacement of all recalled products. Distributors, hospitals, healthcare facilities and clinics, and other healthcare providers that have the recalled product should immediately stop use and/or further distribution, quarantine all affected product inventory, and follow the instructions in the customer recall notification for arranging return of the affected lot to Liebel-Flarsheim Company, LLC.; Product \| NDC \| Lot \| Expiration; OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) Multiple -Dose Container. Packaged in cases of 6 vials \| 0019-1333-65 \| 25ZF3670 \| May 31, 2027; Contact \| Contact Information; Inmar Inc. (Liebel- Flarsheim’s recall processor) \| Email: rxrecalls@inmar.com Phone Number: +1-855-670-3976; Medical Information \| Email: medical.liaison.na@guerbet.com; Pharmacovigilance/Adverse Event Reporting \| Email: pvreporting@guerbet.com |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| Product | NDC | Lot | Expiration |
| --- | --- | --- | --- |
| OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) Multiple -Dose Container. Packaged in cases of 6 vials | 0019-1333-65 | 25ZF3670 | May 31, 2027 |

**FDA company announcement, table 2**

| Contact | Contact Information |
| --- | --- |
| Inmar Inc. (Liebel- Flarsheim’s recall processor) | Email: rxrecalls@inmar.com Phone Number: +1-855-670-3976 |
| Medical Information | Email: medical.liaison.na@guerbet.com |
| Pharmacovigilance/Adverse Event Reporting | Email: pvreporting@guerbet.com |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/liebel-flarsheim-company-llc-issues-recall-optiray-imaging-bulk-package-350-500ml-vial-nationwide).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Aug 4, 2026
- **Company announcement date**: Jul 31, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Consumers with questions regarding this recall can contact Liebel-Flarsheim Company, LLC: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/liebel-flarsheim-company-llc-issues-recall-optiray-imaging-bulk-package-350-500ml-vial-nationwide)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Liebel-Flarsheim Company LLC records](https://isitonrecall.com/brand/liebel-flarsheim-company-llc/)