Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,
Summary
The FDA issued a Class I for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Onl by Fresenius Kabi USA, LLC. Reason: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles..
Details
Source
Drug Recall
External ID
D-0827-2026
Action Date
2026-09-02
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: 16UI07, Exp 08/31/2028
Quantity Affected: 4,643 20mL-vials
Reason for Recall
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-10
Company
Lake Zurich, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 38 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Fresenius Kabi USA, LLC has 51 FDA actions in our database, including 51 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 51 FDA actions in our database, including 51 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0827-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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