Plastic, steel and glass particles found in contrast-agent vials - why particulates matter in a drug that enters the bloodstream (Liebel-Flarsheim)
The U.S. FDA classified as Class I a recall of 3,486 500 mL vials of the X-ray contrast agent Optiray made by Liebel-Flarsheim. The reason is the presence of particulate matter comprising polyethylene and other plastics, stainless steel and glass.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeDrug
- Recalling firmLiebel-Flarsheim Company LLC
- ReasonPresence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
- DistributionDistributed Nationwide in the US and Mexico.
- Recall initiated2026-07-31
Key points
- The product is 3,486 500 mL multiple-dose vials of the X-ray contrast agent Optiray, classified Class I.
- The reason is particulate matter comprising polyethylene and other plastics, stainless steel and glass.
- Because a contrast agent enters the vasculature, particles travel with the blood rather than passing through the digestive tract.
- Distribution reached the whole United States and Mexico.
- Of the 1,408 FDA recall records this site holds as of 2026-09-02, 39 name particulate matter in the reason.
- Only 14 of the 319 Class I records are drugs, against 137 devices and 168 food.
1How a contrast agent is used
A contrast agent is introduced into the body to make vessels and organs easier to distinguish on X-ray or CT images. This product comes as a multiple-dose vial: a large-volume container intended to be drawn from across several examinations. Each time, it is transferred to an injector and delivered into the vasculature.
2Why particles matter on this route
| Material named in the record | What it is |
|---|---|
| Polyethylene | A resin used in containers and components |
| Other plastic materials | As above |
| Stainless steel | A metal that can originate on the equipment side |
| Glass | Possibly fragments of a container or component |
In an oral medicine, fine foreign matter passes through the digestive tract and is excreted. A drug entering the vasculature takes a different route, and particles travel with the blood. That the materials span several kinds suggests the entry path may not be a single one, though the record does not state a cause.
3Particulates are not a rare reason
Class I drug recalls number only 14, and this is one of them. Most drug recalls carry a lighter classification; the most serious one is applied where the route of administration or the patient population makes harm a realistic prospect.
4Distribution across a border
That distribution reached Mexico as well as the whole United States shows a pharmaceutical supply chain built across borders. Notification and retrieval have to proceed across more than one regulator, and how quickly lots can be traced to their destinations governs the pace of the response.
Why it matters
For products entering the vasculature - injectables and infusions - particulate matter becomes a question about process control itself. Where the materials span resin, metal and glass, identifying the entry path takes time and the scope of the recall settles late. Lot-level shipment records and a notification arrangement that works across borders determine how effective the response can be.
FAQ
What foreign matter was found?
Why do particles matter so much in a contrast agent?
How far was it distributed?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: D-0773-2026