Liebel-Flarsheim Company LLC drug recall: Optiray Imaging Bulk Package-350
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99510
- Recall initiated
- Jul 31, 2026
- Classified by FDA
- Aug 19, 2026
- Posted in Enforcement Report
- Aug 19, 2026
- Recalling firm
- Liebel-Flarsheim Company LLC
- Firm location
- Raleigh, NC, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jul 31, 2026. FDA classified it 19 days later, on Aug 19, 2026. Distribution reported by FDA: Distributed Nationwide in the US and Mexico. Liebel-Flarsheim Company LLC has 3 recalls in our records.
Recalled products (1)
D-0773-2026 Class I Ongoing
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.
Codes / lots: Lot # 25ZF3670, Exp Date: May 31, 2027.
Quantity: 3,486 500mL-vials
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 99510
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.