Critical Alert
Liebel-Flarsheim Company LLC Recalls Optiray Imaging Bulk Package-350
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #D-0773-2026Drug / Pharmaceutical
Liebel-Flarsheim Company LLC Recalls Optiray Imaging Bulk Package-350
Liebel-Flarsheim Company LLC · Class I — Most Serious
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.
Reason for Recall
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Distributed Nationwide in the US and Mexico.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class I recall — the most serious classification reserved for situations where there is a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death. Liebel-Flarsheim Company LLC initiated this recall of pharmaceutical product on July 31, 2026 affecting 3,486 500mL-vials. Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. The product was distributed nationwide. Consumers who have this product should stop using it immediately and contact the recalling firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.