FDA Drug recall D-0827-2026
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
- FDA Drug
- Class I
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class I recall of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il… by Fresenius Kabi Usa, citing presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0827-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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.
Reason
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Identifiers
| ndc | 65219-590-04 |
|---|---|
| ndc | 65219-592-10 |
| ndc | 65219-594-20 |
| code_info | Lot: 16UI07, Exp 08/31/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0827-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.