Recall
FDAHealthJuly 31, 2026

Liebel-Flarsheim Company LLC — 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: Lieb

⚠️ Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 31, 2026

Distributed Nationwide in the US and Mexico.

What's affected?

Product
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.
Brand
OPTIRAY
UPC
0300191332653
Lot code
25ZF3670

Additional details

Lot # 25ZF3670, Exp Date: May 31, 2027.

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 3,486 500mL-vials.

View original FDA notice →

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