Stop using now Drug recall · FDA · Published August 10, 2026

Fresenius Kabi Tyenne Injection Recall: Glass Particles Hazard

Fresenius Kabi recalls Tyenne (tocilizumab-aazg) injection due to glass particles found in some batches. This may cause serious injury if injected. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0827-2026Drug Fresenius Kabi ›

Fresenius Kabi — official photo 1 — Official FDA recall photos · click to enlarge

Stop using this now

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

✎ GovInfoNow plain-language explainer

Fresenius Kabi is recalling Tyenne injections that contain glass particles, which could cause serious injury if injected. This recall affects specific batches with lot number 16UI07 and expiration date 08/31/2028. Read more at govinfonow.com/recall/692850-fresenius-kabi-tyenne-injection-recall-glass-particles-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/692850-fresenius-kabi-tyenne-injection-recall-glass-particles-hazard · Updated September 14, 2026 · FDA enforcement record: FDA #D-0827-2026

Cite this page

“Fresenius Kabi Tyenne Injection Recall: Glass Particles Hazard.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692850-fresenius-kabi-tyenne-injection-recall-glass-particles-hazard. Based on FDA recall #D-0827-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0827-2026%22&limit=1).

The FDA announced on 2026-08-10 that Fresenius Kabi USA, LLC is recalling Tyenne (tocilizumab-aazg) Injection due to the presence of glass particles. The voluntary Class I recall affects 4,643 vials distributed nationwide.

How to tell if you have it

Brand: Fresenius Kabi
Product: Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial
NDC: 65219-594-20
Lot: 16UI07
Expiration: 08/31/2028

The hazard

An internal investigation found the product contains glass particles. The recall is classified as Class I, indicating a situation where use could cause serious adverse health consequences or death.

Context

GovInfoNow's records show Fresenius Kabi USA, LLC has had 65 other recalls since 2012-09-27. Recent brand recalls include Morphine Syringes with wrong labeling on 2026-08-04 and Naropin Injection with hair particles on 2026-07-16. Other recent recalls of similar products include Tri-Moxi+ Intraocular Injection with glass particles risk (2025-12-18), Ketamine HCl Injection lacking sterility assurance (2026-02-05), and DOXOrubin Liposome Injection with glass particulate risk (2026-05-12).

How to tell if you have this one

Check the product label for the lot number 16UI07 and expiration date 08/31/2028. The product is a 20 mL vial of Tyenne injection, 400 mg/20 mL (20 mg/mL), prescription-only.

Brand
Fresenius Kabi
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using the recalled Tyenne injection if you have the lot number 16UI07 and expiration date 08/31/2028.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 23 days after the firm started it.

Aug 10, 2026Firm started the recall
Sep 1, 2026FDA classified it Class I
Sep 2, 2026Published in FDA’s Enforcement Report
Sep 8, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/692850-fresenius-kabi-tyenne-injection-recall-glass-particles-hazard">Fresenius Kabi Tyenne Injection Recall: Glass Particles Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0827-2026 (August 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0827-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.