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Voluntary nationwide recall: Tyenne (Fresenius – August 2026)
UPMC Health Plan·Rheumatology, Internal Medicine, Pharmacy·Pharmacy
Effective date
Aug 10, 2026
We identified it
Aug 26, 2026
Summary
Fresenius Kabi has issued a voluntary nationwide recall of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL, lot 16UI07, due to glass particle contamination. Billing teams must identify affected patients, halt claims processing for this lot, and coordinate with providers and patients to prevent administration of contaminated product.
Action Required
Immediately: (1) Billing team must identify all claims submitted for Tyenne lot 16UI07 since August 2026 in the billing system. (2) Flag and hold any claims for this specific lot pending verification of patient safety. (3) Notify providers and clinical staff to verify patient lot numbers and confirm no contaminated product was administered. (4) Update billing system to reject or flag any future claims for lot 16UI07. (5) Contact affected patients through the clinical team if any doses from this lot were dispensed. Document all actions taken. Failure to process these recalls could result in patient harm from glass particle injection, potential liability claims, and regulatory scrutiny. Reference Fresenius Kabi Quality Assurance at 866-716-2459 (Monday-Friday, 8 a.m.–5 p.m. CST) or FDA website for lot verification.