drugs HIGH RISK Updated 2026-09-02

Fresenius Kabi USA, LLC recalls Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL)

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Recalled 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.

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Hazard / Issue

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: 16UI07, Exp 08/31/2028

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall