FDA Drug recall · Reported August 19, 2026
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.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Liebel-Flarsheim Company LLC recalled Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iod… - a critical-severity action.
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iod… was recalled by Liebel-Flarsheim Company LLC in August 19, 2026. Reason: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glas…. Check the official notice for the remedy. Verify recall #D-0773-2026 with the FDA Drug before acting.
The recall
Liebel-Flarsheim Company LLC issued this critical-severity FDA Drug recall-Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glas….
- Critical
- severity level
- Class I
- classification
- August 19, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0773-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0773-2026) was formally reported on August 19, 2026, with the manufacturer initiating the action on July 31, 2026. It is classified under Critical severity (Class I), with a current status of Ongoing. Liebel-Flarsheim Company LLC is listed as the recalling firm, operating out of Raleigh, NC. Federal records list the affected scope as 3,486 500mL-vials.
The documented reason for this recall is: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. Distribution data in the federal record shows the product reached: Distributed Nationwide in the US and Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,472 drugs & medications recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0773-2026 |
| Date reported | August 19, 2026 |
| Date initiated | July 31, 2026 |
| Recalling firm | Liebel-Flarsheim Company LLC |
| Firm location | Raleigh, NC |
| Affected scope | 3,486 500mL-vials |
| Distribution | Distributed Nationwide in the US and Mexico. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0773-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026