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.
Class I · Ongoing
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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Affected lots / codes — check yours against thisLot: 16UI07, Exp 08/31/2028
- Recalling firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Classification
- Class I (most serious — risk of serious harm)
- Status
- Ongoing
- Quantity
- 4,643 20mL-vials
- Distribution
- Nationwide in the USA
- Recall initiated
- August 10, 2026
- Classified
- September 1, 2026
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0827-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0827-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →