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Class I · Most seriousActive recall

Optiray

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # 25ZF3670, Exp Date: May 31, 2027.
Where it was soldDistributed Nationwide in the US and Mexico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLiebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA
Brand nameOPTIRAY
Generic nameIOVERSOL
Active ingredient(s)IOVERSOL
Distributed by / forLiebel-Flarsheim Company LLC
NDC0019-1333-65
Show the full FDA record
Full product labelOptiray 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 firmLiebel-Flarsheim Company LLC
DistributionDistributed Nationwide in the US and Mexico.
Quantity3,486 500mL-vials
Recall initiated2026-07-31
Report date2026-08-19
Recall completed—
Recall numberD-0773-2026
ClassificationClass I
FDA statusOngoing
Origin on fileRaleigh NC United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.