Which Tyenne product does the Fresenius Kabi recall cover?

The recall includes only Tyenne® (tocilizumab-aazg) 400 mg/20 mL single-dose vials from lot 16UI07.

Why is Fresenius Kabi recalling Tyenne lot 16UI07?

Quality testing revealed glass particles in finished vials, creating a potential for injection-site injury or serious embolic events.

How can I confirm that my Tyenne inventory is part of the recall?

Verify the NDC 65219-594-20, product code 590120, lot 16UI07 and expiration 08/2026 on the vial carton and label.

What should a hospital do if it has unused Fresenius Kabi Tyenne vials from the affected lot?

Immediately quarantine the vials, contact Fresenius Kabi Quality Assurance at 1-866-716-2459 and follow the provided return instructions.

How do I report a reaction linked to the recalled Fresenius Kabi Tyenne?

File a report through FDA MedWatch online or by using Form 3500 obtained via FDA.gov and submit it by mail or fax.

FDA Recall: Fresenius Kabi Tyenne Injection 400 mg/20 for Due to Presence of Glass Particles

Source: FDA

File Your Claim Now

FDA Recall: Fresenius Kabi Tyenne Injection 400 mg/20 for Due to Presence of Glass Particles

Fresenius Kabi • August 11, 2026

Fresenius Kabi Recalls Tyenne (tocilizumab-aazg) Injection After Glass Particles Found

Action required now: Fresenius Kabi is voluntarily recalling one lot of Tyenne® (tocilizumab-aazg) 400 mg/20 mL vials because internal testing revealed visible glass particles. Healthcare professionals must immediately stop using lot 16UI07, quarantine any remaining inventory, and coordinate returns for credit or replacement.

Recall overview and risk statement

Glass contamination in injectable drugs can:

Cause local irritation, pain or swelling at the infusion site
Lead to phlebitis (vein inflammation)
Obstruct blood vessels, potentially resulting in pulmonary embolism, organ damage or death

Tyenne recall specifics

The recall involves a single lot shipped nationwide to wholesalers, distributors and direct hospital accounts between 03/03/2024 – 03/25/2024.

Product: Tyenne® (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL)
NDC: 65219-594-20
Product code: 590120
Lot number: 16UI07
Expiration date: 08/2026

Primary source

FDA recall announcement

Approved uses for Tyenne

The FDA has approved Tyenne for treatment of:

Moderately to severely active rheumatoid arthritis in adults
Giant cell arteritis in adults
Polyarticular juvenile idiopathic arthritis in patients ≥ 2 years
Systemic juvenile idiopathic arthritis in patients ≥ 2 years
Severe or life-threatening cytokine release syndrome following CAR-T therapy in patients ≥ 2 years
Certain hospitalized adults with COVID-19 who require supplemental oxygen or ventilation

Required actions for distributors and facilities

Cease dispensing or administering Tyenne lot 16UI07.
Isolate affected vials and arrange returns through Fresenius Kabi’s recall coordinator.
Inform all relevant departments, pharmacies and satellite clinics of the recall.

Key Fresenius Kabi contacts

• Quality Assurance: 1-866-716-2459 (Mon–Fri, 8 a.m.–5 p.m. CST)
• Medical Affairs & Vigilance: 1-800-551-7176
productcomplaint.USA@fresenius-kabi.com
adverse.events.USA@fresenius-kabi.com

How to report side effects

Adverse events associated with Tyenne should also be reported to FDA MedWatch:

Online: www.fda.gov/medwatch/report.htm
Mail or fax: download Form 3500 at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088.

Official recall image

Fresenius Kabi Tyenne 400 mg/20 mL vial – recalled lot 16UI07 — Source: FDA

Frequently asked questions about the Fresenius Kabi Tyenne recall

1. Which Tyenne product does the Fresenius Kabi recall cover?: The recall includes only Tyenne® (tocilizumab-aazg) 400 mg/20 mL single-dose vials from lot 16UI07.
2. Why is Fresenius Kabi recalling Tyenne lot 16UI07?: Quality testing revealed glass particles in finished vials, creating a potential for injection-site injury or serious embolic events.
3. How can I confirm that my Tyenne inventory is part of the recall?: Verify the NDC 65219-594-20, product code 590120, lot 16UI07 and expiration 08/2026 on the vial carton and label.
4. What should a hospital do if it has unused Fresenius Kabi Tyenne vials from the affected lot?: Immediately quarantine the vials, contact Fresenius Kabi Quality Assurance at 1-866-716-2459 and follow the provided return instructions.
5. Can patients continue therapy with other lots of Tyenne?: Yes. Only lot 16UI07 is impacted. Other lots of Fresenius Kabi Tyenne remain unaffected and may be used as labeled.
6. How do I report a reaction linked to the recalled Fresenius Kabi Tyenne?: File a report through FDA MedWatch online or by using Form 3500 obtained via FDA.gov and submit it by mail or fax.