Fresenius Kabi USA, LLC drug recall: Tyenne
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99603
- Recall initiated
- Aug 10, 2026
- Classified by FDA
- Sep 1, 2026
- Posted in Enforcement Report
- Sep 2, 2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Lake Zurich, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 10, 2026. FDA classified it 22 days later, on Sep 1, 2026. Distribution reported by FDA: Nationwide in the USA Fresenius Kabi USA, LLC has 67 recalls in our records.
Recalled products (1)
D-0827-2026 Class I Ongoing
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.
Codes / lots: Lot: 16UI07, Exp 08/31/2028
Quantity: 4,643 20mL-vials
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 99603
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.