Class III · Low risk
Optiray Imaging Bulk Package-350 (Ioversol)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
0019-1333-65
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Optiray 350 Ioversol NDC 00019-1333 |
741 mg/mL | Injection Intra-Arterial|intravenous |
Liebel-Flarsheim Company LLC | Rx |
- Recalling firm
- Liebel-Flarsheim Company LLC
- NDC code
- 0019-1333-65
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jul 31, 2026 · FDA notice with lot numbers
- FDA recall number
- D-0773-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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Other particulate / foreign matter recalls from 2026
All particulate / foreign matter recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
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Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
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