Tyenne (tocilizumab-aazg) Injection recall
FDA recall D-0827-2026 · initiated Aug 10, 2026
Fresenius Kabi USA, LLC recalled Tyenne (tocilizumab-aazg) Injection in Aug 2026 — an FDA Class I recall (D-0827-2026) because Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,643 20mL-vials
Details
- Product
- 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.
- Recalling company
- Fresenius Kabi USA LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 10, 2026
- FDA report date
- Sep 2, 2026
This recall is linked to a product we cover: Tyenne →
Frequently asked
- Was Tyenne (tocilizumab-aazg) Injection recalled?
- Fresenius Kabi USA, LLC recalled Tyenne (tocilizumab-aazg) Injection in Aug 2026 — an FDA Class I recall (D-0827-2026) because Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Tyenne (tocilizumab-aazg) Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0827-2026 was: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Is a recalled Tyenne (tocilizumab-aazg) Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tyenne (tocilizumab-aazg) Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: 16UI07, Exp 08/31/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0827-2026.