Optiray Imaging Bulk Package-350 recall
FDA recall D-0773-2026 · initiated Jul 31, 2026
Liebel-Flarsheim Company LLC recalled Optiray Imaging Bulk Package-350 in Jul 2026 — an FDA Class I recall (D-0773-2026) because Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,486 500mL-vials
Details
- 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.
- Recalling company
- Liebel-Flarsheim
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the US and Mexico.
- Initiated
- Jul 31, 2026
- FDA report date
- Aug 19, 2026
This recall is linked to a product we cover: Optiray 350 →
Frequently asked
- Was Optiray Imaging Bulk Package-350 recalled?
- Liebel-Flarsheim Company LLC recalled Optiray Imaging Bulk Package-350 in Jul 2026 — an FDA Class I recall (D-0773-2026) because Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Optiray Imaging Bulk Package-350 recalled?
- Per the FDA enforcement record, the reason for recall D-0773-2026 was: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
- Is a recalled Optiray Imaging Bulk Package-350 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Optiray Imaging Bulk Package-350 are affected?
- Distributed: Distributed Nationwide in the US and Mexico.. The recall covers these lots — Lot # 25ZF3670, Exp Date: May 31, 2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0773-2026.