Class I U.S. Food and Drug Administration

Fresenius Kabi Tyenne Injection 400 mg/20 mL vial recall: Due to Presence of Glass Particles

Recall published 3 months ago

Due to Presence of Glass Particles

Fresenius Kabi Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — glass

This is a foreign-material recall — glass where there should be none. An affected pack looks identical to a sound one from the outside.

What the notice says: Risk Statement: The administration of an injectable product containing glass particulates may cause local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins.

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
August 10, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Kabi
Product type
Prescription & OTC drugs
Units affected
4,643 20mL-vials
Distribution
Nationwide
Lot / code info
Lot: 16UI07, Exp 08/31/2028

Products covered by this recall

Tyenne Injection 400 mg/20 mL vial

What the company announced

August 10, 2026 – LAKE ZURICH, Ill.— Fresenius Kabi, an operating company of the Fresenius Group, is recalling one lot of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL vials to the user level. An internal investigation at the firm found the product to contain glass particles.

Risk Statement: The administration of an injectable product containing glass particulates may cause local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins. More seriously, glass particles can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death.

Tyenne® (tocilizumab-aazg) Injection is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs); adult patients with giant cell arteritis; patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis; patients 2 years of age and older with active systemic juvenile idiopathic arthritis; adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome; and certain hospitalized adult patients with COVID-19.

Recalled product can be identified as follows (with label below):

  • Product Name/Size: Tyenne® (tocilizumab-aazg) Injection, 400 mg / 20 mL (20mg/mL) 20 mL vial · NDC Number: 65219-594-20 · Product Code: 590120 · Lot Number: 16UI07 · Expiration Date: 08/2028 · First Ship Date: 03/03/2026 · Last Ship Date: 03/25/2026

Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL)20 mL was distributed nationwide to wholesalers, distributors and direct customers.

Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lot, they are to immediately discontinue distributing, dispensing, or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time or send an e-mail to either [email protected] or [email protected] .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 8 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

Best-by / use-by date

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

  • 08/2028
  • 08/31/2028

NDC number

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

  • 65219-594-20

Model or item number

On the rating label, the box or the instruction sheet.

  • 590120

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 — Company recall announcements 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 — This is a foreign-material recall — glass where there should be none. An affected pack looks identical to a sound one from the outside.

  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.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Fresenius Kabi — Consumers: (800) 551-7176, [email protected] — Media: Matt Kuhn, (847) 220-3033

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 — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fresenius Kabi prescription & otc drugs recalled?

Due to Presence of Glass Particles Risk Statement: The administration of an injectable product containing glass particulates may cause local irritation, pain, or swelling at the infusion site, as well as inflammation of the veins.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 16UI07; best-by date 08/2028 or 08/31/2028; model number 590120. 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?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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