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Fresenius Kabi

Controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2026

    Fresenius Kabi recalls Tyenne arthritis injection lot over glass particles

    Recall announced

    Fresenius Kabi initiated a nationwide recall of one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after an internal investigation found glass particles in the product, which the company warned could cause local irritation, vein inflammation, blood vessel blockage and clotting, pulmonary embolism, permanent organ damage or death. The recall, announced by the FDA on Aug. 11, covers lot 16UI07 (NDC 65219-594-20), shipped between March 3 and 25, 2026, with an August 2028 expiration date, and sold to wholesalers, distributors and customers across the United States.

    Company response

    • Recall — Fresenius Kabi

      Fresenius Kabi, a pharmaceutical company based in Illinois, has initiated a nationwide recall of one lot of an arthritis injection medication due to the presence of glass particles.

    • Ongoing disclosure — Fresenius Kabi

      According to the announcement, Fresenius Kabi is currently notifying customers and distributors through letters and is arranging for the recalled products to be returned.

    Source excerpt

    • According to the announcement, Fresenius Kabi is currently notifying customers and distributors through letters and is arranging for the recalled products to be returned.
    • The recall applies to Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL (20 mg/mL) 20 mL vials, the company said in an announcement published by the Food and Drug Administration on Aug. 11.
    • Fresenius Kabi, a pharmaceutical company based in Illinois, has initiated a nationwide recall of one lot of an arthritis injection medication due to the presence of glass particles.
    Source

  2. 2020

    QuVa Pharma recalls R.E.C.K. product lots

    Recall announced

    QuVa Pharma announced a voluntary recall of all lots of its R.E.C.K. 50 ml product prepared using ketorolac that had been recalled by Fresenius Kabi. QuVa stated that it contacted affected hospital pharmacy customers and asked them to quarantine remaining product, report unused quantities, and return finished goods for destruction. The source reports that the ketorolac recall was due to particulate matter found in reserve sample vials.

    Source excerpt

    • QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi.
    • QuVa has reached out to all hospital pharmacy customers who purchased product from the lots affected and has asked them to: quarantine anything that is in stock to prevent use in direct patient care; complete a return response form to capture the amount of unused product; and return the finished goods to QuVa for destruction.
    • Fresenius Kabi recalled multiple lots of Ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials.
    Source