Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial,
Summary
The FDA issued a Class I for Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically by Liebel-Flarsheim Company LLC. Reason: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass..
Details
Source
Drug Recall
External ID
D-0773-2026
Action Date
2026-08-19
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot # 25ZF3670, Exp Date: May 31, 2027.
Quantity Affected: 3,486 500mL-vials
Reason for Recall
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Distribution
Distributed Nationwide in the US and Mexico.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-31
Company
Raleigh, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 28 drug recalls issued in the same week, part of 68 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Liebel-Flarsheim Company LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Liebel-Flarsheim Company LLC have FDA actions?
This is the only FDA action we have on record for Liebel-Flarsheim Company LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0773-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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