Fresenius Kabi Usa, Llc: Tyenne (tocilizumab-aazg) Injection, 400 Mg/20 Ml (20 Mg/ml)
Recall Summary Fresenius Kabi USA is recalling Tyenne (tocilizumab-aazg) Injection, a medication used to treat inflammatory conditions, because the product was found to contain glass particles. The recall affects the 400 mg/20 mL vial (NDC 65219-594-20) and applies to supplies distributed nationwide across all U.S. states and Washington, D.C.
- Recalling firm
- Fresenius Kabi USA, LLC
- 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, 60047, NDC 65219-594-20.
- Reason
- Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-10
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/edba3392-cb25-4025-bcaf-4481515f5500