CLASS I ONGOING Drug recall · Reported 2 Sep 2026 · FDA Enforcement Report
Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalled
Fresenius Kabi USA is recalling Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial, distributed nationwide in the US. The recall was initiated on 10 Aug 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0827-2026
- FDA event ID
- 99603
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Tyenne
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 10 Aug 2026
- FDA classified
- 1 Sep 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Aug 2026 | Recall initiated by company | |
| 1 Sep 2026 | Classified by FDA | +22 days |
| 2 Sep 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Which lots are affected?
Lot: 16UI07, Exp 08/31/2028
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 94| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |