Voluntary nationwide recall: Tyenne (Fresenius – August 2026)
Fresenius Kabi is recalling one lot, lot 16UI07, of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL) 20 mL vials. Tyenne is used for the treatment of certain arthritis conditions.
This drug is being recalled because glass particles were found in the product. Using an injectable product that contains glass particles may cause local irritation, pain, or swelling. It may also block blood vessels, leading to life-threatening blood clot events.
To see if your medication was recalled, contact your doctor or pharmacy where you received it or visit the FDA website below. If you have an affected lot of Tyenne or are experiencing any problems that may be related to receiving the product, you should stop using it and talk to your doctor.
As of Aug. 10, there had been no reports of adverse events related to this recall.
To learn more about this recall, you can take one or more of the steps below.
- Talk to your doctor or pharmacist.
- Call Fresenius Kabi USA Quality Assurance at 866-716-2459. TTY users should call 711. Help is available Monday through Friday from 8 a.m. to 5 p.m. CST.
- Visit the FDA website.