Recall archive / 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. Source coverage and dates.

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

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: [email protected] Phone Number: +1-855-670-3976; Medical Information \| Email: [email protected]; Pharmacovigilance/Adverse Event Reporting \| Email: [email protected]

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: [email protected] Phone Number: +1-855-670-3976; Medical Information | Email: [email protected]; Pharmacovigilance/Adverse Event Reporting | Email: [email protected]

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: [email protected] Phone Number: +1-855-670-3976
Medical Information	Email: [email protected]
Pharmacovigilance/Adverse Event Reporting	Email: [email protected]

Announcement retrieved Oct 1, 2026. Official announcement.

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.