Tyenne Injection 400 mg/20mL Recall: Particulate Matter
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…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Tyenne Injection 400 mg/20mL recalled?
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
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.
Which lot codes, UPCs or models are affected?
Lot: 16UI07, Exp 08/31/2028
- Agency record number
- D-0827-2026
- Product
- 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…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 4,643 20mL-vials
- Distribution
- Nationwide in the USA
- Recall started
- August 10, 2026
- Report date
- September 2, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)