FDA Drug recall D-0773-2026
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile S…
- FDA Drug
- Class I
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class I recall of Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile S… by Liebel Flarsheim, citing presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0773-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-07-31 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Liebel Flarsheim |
| Distribution | US |
Product
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
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Identifiers
| ndc | 0019-1333-65 |
|---|---|
| ndc | 0019-1323-65 |
| ndc | 0019-1332-65 |
| code_info | Lot # 25ZF3670, Exp Date: May 31, 2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0773-2026%22
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