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FDA recall, , High risk

Tyenne (Tocilizumab-Aazg) Injection

Tyenne (tocilizumab-aazg) Injection contains glass particles that can cause irritation, swelling, vein inflammation, blood clots, and organ damage.

Summary by Recall Canary from the FDA notice

What happened

Fresenius Kabi USA, LLC, of Lake Zurich, Illinois, began a recall on August 10, 2026, of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, due to the presence of glass particles. The recall was announced on August 10, 2026, and added to the FDA's Enforcement Report on August 24, 2026. The product was distributed nationwide in the USA.

An internal investigation at the firm found the product to contain glass particles. The recall was classified by the FDA on September 1, 2026, and in the FDA's weekly enforcement report on September 2, 2026.

More foreign object recalls

What to do

If a code on your package is listed below:

  1. 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.
  2. Contact your physician or health care provider if you have experienced any problems that may be related to receiving this drug product.
  3. 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.
  4. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.

Is yours affected?

Match the lot code, best-by or expiration date and NDC listed under your product.

An NDC (National Drug Code) is usually printed on the drug's label.

  1. Tyenne® (tocilizumab-aazg) Injection, 400 mg 20 mL (20mg/mL) 20 mL vial

    NDC
    • 65219-594-20
    Lot code
    • 16UI07
    Best-by or expiration date
    08/2028
    First ship date
    03/03/2026
    Last ship date
    03/25/2026

Recall details

Company began the recall
Sold in

Nationwide in the USA

Company
Fresenius Kabi USA, LLCLake Zurich, Illinois
Hazard
Foreign object
Risk

High risk

There is a reasonable chance that taking it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
99603
Recall number
D-0827-2026
Quantity recalled
4,643 20mL-vials

All recalls from Fresenius Kabi USA, LLC

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall · Announced by the company

  2. Listed on Recall Canary

  3. Added to FDA's Enforcement Report

  4. Classified by FDA

  5. In FDA's weekly enforcement report

  6. Summary updated

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Summary by Recall Canary, written with AI · summary updated Oct 7, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)