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FDA Closes Fresenius Kabi Recall of 4,643 Tyenne Vials

The FDA has terminated its Class I enforcement action over glass particles in Tyenne (tocilizumab-aazg) Injection, meaning the agency considers the recall carried out.

2 reports on this incident · first at Sep 9, 2026, 9:42 p.m. ET

By AI ReporterWritten Sep 9, 2026, 9:54 p.m. ET
Developing · checked 2h ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Sep 9, 2026, 9:10 p.m. ET — checked 2h ago.

The FDA has closed its recall of 's Tyenne (tocilizumab-aazg) Injection, according to the agency's enforcement report for recall number . The action was terminated, meaning the agency considers the recall carried out. The recall covered 4,643 20mL vials of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, manufactured by , , Illinois, 60047, NDC 65219-594-20, according to the enforcement report. The affected lot is 16UI07, with an expiration date of 08/31/2028. The FDA classified the action as , its most serious category, used where there is a reasonable probability that using the product will cause serious harm or death, according to the agency's recall definitions. The reason given in the enforcement report was the presence of particulate matter: an internal investigation at the firm found the product to contain glass particles. The recall was initiated on and reported on , according to the enforcement report. Distribution was . The FDA's database records no other enforcement action by this firm. Tyenne is a prescription-only finished biological product, a liquid solution made from a recombinant humanized monoclonal antibody produced in Chinese hamster ovary cells, sold in a single-dose vial for healthcare professionals to dilute and administer via intravenous infusion, according to FDA and NIH descriptions.

Earlier reports

  1. Sep 9, 2026, 9:42 p.m. ETFirst report

    Fresenius Kabi Recalls 4,643 Vials of Tyenne Injection Over Glass Particles

    Fresenius Kabi USA, LLC, of Lake Zurich, Illinois, is recalling 4,643 20 mL vials of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), according to an FDA enforcement report issued under recall number D-0827-2026. The recall was initiated on August 10, 2026, and reported on September 2, 2026, and its status is ongoing.

    The FDA classified the action as Class I, the agency's most serious category, used where there is a reasonable probability that using the product will cause serious harm or death. The stated reason is the presence of particulate matter: an internal investigation at the firm found the product to contain glass particles.

    The affected product carries lot number 16UI07 and an expiration date of 08/31/2028, and is identified by NDC 65219-594-20. It is distributed nationwide in the USA. Tyenne (tocilizumab-aazg) Injection is a prescription-only biological drug product supplied as a sterile concentrate solution intended to be diluted and administered via intravenous infusion, according to FDA and NIH descriptions of the product.

    The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Revision history

  1. Version 110 Sept 2026, 01:42current

    First published.

  2. Version 110 Sept 2026, 01:54current

    First published.

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