July 2026 FDA Recall Optiray by Liebel-flarsheim Company Llc
D-0773-2026 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Liebel-flarsheim Company Llc on July 31, 2026 for the product Optiray. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0773-2026
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
07-31-2026
08-19-2026
3,486 500mL-vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Liebel-Flarsheim Company LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the US and Mexico.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# 25ZF3670, Exp Date: May 31, 2027.
