Urgent site urgencyFDA Class I

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-Flarshei

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Agency
FDA Drug
Recall date
Jul 31, 2026
Status
Ongoing
Company
Liebel-Flarsheim Company LLC
OPTIRAY Imaging Bulk Package (IBP) 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml), label example
Image supplied with the official CPSC notice.

1. What product was recalled?

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-Flarshei

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.

Quantity: 3,486 500mL-vials

Code or lot text: Lot # 25ZF3670, Exp Date: May 31, 2027.

LOT
2027.
LOT
Exp Date: May 31
LOT
Lot # 25ZF3670
NDC
0019-1323
NDC
0019-1323-65
NDC
0019-1332
NDC
0019-1332-65
NDC
0019-1333
NDC
0019-1333-65
RECALL-NUMBER
D-0773-2026
UPC
0300191323651
UPC
0300191332653
UPC
0300191333650

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Drug source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.