Optiray Imaging Bulk Package-350 — Class I drug recall D-0773-2026
Ongoing recall by Liebel-Flarsheim Company LLC, reported 2026-08-19, distributed nationwide. Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass
| Recall number | D-0773-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Liebel-Flarsheim Company LLC, Raleigh, NC, United States |
| Recall initiated | 2026-07-31 |
| Classified | 2026-08-19 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 3,486 |
| Reason classes | foreign material, specification failure |
| NDC | 00019-1323, 00019-1323-65, 00019-1332, 00019-1332-65, 00019-1333, 00019-1333-65 |
| Lot numbers | 25ZF3670 |
| Expiration dates | 2027-05-31 |
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 for recall
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0773-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.