Tyenne — Class I drug recall D-0827-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-09-02, distributed nationwide. Presence of particulate matter:An internal investigation at the firm found the product to contain glass partic
| Recall number | D-0827-2026 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2026-08-10 |
| Classified | 2026-09-01 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 4,643 |
| Reason classes | foreign material, specification failure |
| NDC | 65219-0590, 65219-0590-04, 65219-0592, 65219-0592-10, 65219-0594, 65219-0594-20 |
| Lot numbers | 16UI07 |
| Expiration dates | 2028-08-31 |
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 for recall
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0827-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.