Optiray Injection
FDA Recall NDC 0019-1323
Latest: Class I · Status: Ongoing · Initiated Jul 31, 2026 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Optiray (NDC 0019-1323). A significant event, classified as Class I, was initiated on Jul 31, 2026 by Liebel-flarsheim Company Llc. The reported reason for this action was: "Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Jul 31, 2026
Aug 19, 2026
3,486 500mL-vials
Recall Profile & Regulatory Data
Event ID
99510
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Liebel-Flarsheim Company LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US and Mexico.
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.
Batch or Lot Expiration Information
Lot# 25ZF3670, Exp Date: May 31, 2027.
Affected Packages Involved in this Recall
0019-1333-65Optiray 320
0019-1323-65Optiray 320
0019-1332-65Optiray 320
Class II Terminated
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Sep 13, 2019
Oct 16, 2019
3860 syringes
Recall Profile & Regulatory Data
Event ID
83798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GUERBET LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 25, 2021
Product Description
Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00.
Batch or Lot Expiration Information
Lot# Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
Affected Packages Involved in this Recall
0019-1333-06Optiray 320
0019-1333-11Optiray 320
0019-1333-16Optiray 320
0019-1333-21Optiray 320
0019-1333-75Optiray 320
0019-1333-77Optiray 320
0019-1333-91Optiray 320
0019-1333-83Optiray 320
0019-1333-81Optiray 320
0019-1333-78Optiray 320
0019-1333-52Optiray 320
0019-1333-95Optiray 320
0019-1333-90Optiray 320
0019-1333-87Optiray 320
0019-1333-55Optiray 320
0019-1333-85Optiray 320
0019-1333-00Optiray 320
0019-1333-27Optiray 320
0019-1323-06Optiray 320
0019-1323-11Optiray 320
0019-1323-16Optiray 320
0019-1323-21Optiray 320
0019-1323-73Optiray 320
0019-1323-75Optiray 320
0019-1323-77Optiray 320
0019-1323-91Optiray 320
0019-1323-83Optiray 320
0019-1323-81Optiray 320
0019-1323-70Optiray 320
0019-1323-78Optiray 320
0019-1323-52Optiray 320
0019-1323-95Optiray 320
0019-1323-90Optiray 320
0019-1323-87Optiray 320
0019-1323-55Optiray 320
0019-1323-85Optiray 320
0019-1323-00Optiray 320
0019-1323-27Optiray 320
0019-1323-02Optiray 320
0019-1323-04Optiray 320
0019-1332-06Optiray 320
0019-1332-11Optiray 320
0019-1332-16Optiray 320
0019-1332-21Optiray 320
0019-1332-75Optiray 320
0019-1332-78Optiray 320
0019-1332-91Optiray 320
0019-1332-83Optiray 320
0019-1332-90Optiray 320
0019-1332-00Optiray 320
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
