Fresenius Kabi recall: Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only…
Fresenius Kabi USA, LLC is recalling Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only… because of glass pieces – 4,643 20mL-vials. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on August 10, 2026. Distributed nationwide.
Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.
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| Product | Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only… |
| Brand | Fresenius Kabi |
| Company | Fresenius Kabi USA, LLC |
| Type | Drugs |
| Classification | Class I |
| Recall date | August 10, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | 4,643 20mL-vials |
| Recall ID | 99603 |
Recalled products
- 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.
- FDA recall number
- D-0827-2026
- Codes, lots and dates
- Lot: 16UI07, Exp 08/31/2028
- Quantity
- 4,643 20mL-vials
- Classification
- Class I
Identifiers and details
- FDA event ID
- 99603
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Lake Zurich, IL, United States
Why it was recalled
The problem: glass pieces.
The reason the FDA lists: “Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide in the USA”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99603, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Fresenius Kabi recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Aug 26, 2026 |  Fresenius Kabi recall: Morphine Sulfate InjectionDrugs · 625500 syringes | Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syri… Most serious | FDA Class I |
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| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Fresenius Kabi Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only… recalled?
Yes. Fresenius Kabi USA, LLC recalled it on August 10, 2026; FDA published it September 2, 2026 (Class I). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of glass pieces. The reason given: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.