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FDA recall 99510: Liebel-Flarsheim Company LLC: Optiray Imaging Bulk Package-350

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FDARecall 99510Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

Why it was recalled

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Text from FDA, unedited.

FDA classification: Class I. FDA’s highest class: a reasonable probability that using the product will cause serious health consequences or death. Status: Ongoing.

Is it yours? Products and codes

  • 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 or code
    Lot # 25ZF3670, Exp Date: May 31, 2027.
    FDA recall number
    D-0773-2026
    Quantity
    3,486 500mL-vials

Distribution (FDA): Distributed Nationwide in the US and Mexico.

About this record

Issued by
U.S. Food and Drug Administration
Firm
Liebel-Flarsheim Company LLC
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

About this recall

What is the hazard?

FDA states: “Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.”

What should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

When was this recall published?

FDA published recall 99510 on August 19, 2026.

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