Class I U.S. Food and Drug Administration

Fresenius Kabi USA, LLC Tyenne Injection, 400 mg/20 mL , 20 mL vial recall: Presence of particulate matter:An internal investigation at the firm found

Recall published last month

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

The hazard: Foreign material — glass

Fragments of glass may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

What the notice says: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Why it matters: Pieces of glass may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: glass is usually visible on an X-ray, and a swallowed shard is one of the cases where imaging is worth doing.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0827-2026
Published
September 2, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Kabi USA, LLC
Product type
Prescription & OTC drugs
Units affected
4,643 20mL-vials
Distribution
Nationwide
Made in
United States
Lot / code info
Lot: 16UI07, Exp 08/31/2028

Products covered by this recall

Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 16UI07
  • Exp 08
  • 31
  • 2028 — 4
  • 643 20mL-vials

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08
  • 31
  • 2028 — 4
  • 643 20mL-vials

NDC number

On the carton and again on the bottle or blister label.

  • 65219-594-20

Package size

Match the net weight or the piece count on the front of the pack.

  • 400 mg
  • 20 mL
  • 20 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Glass pieces

Fresenius Kabi USA, LLC — Fragments of glass may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  3. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  4. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Company contact: Fresenius Kabi USA, LLC — 3 Corporate Dr, Lake Zurich, IL, 60047-8930

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fresenius Kabi USA, LLC prescription & otc drugs recalled?

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 16UI07, Exp 08, 31; best-by date 08 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls