Fresenius Kabi USA, LLC Recalls

2 recalls found for Fresenius Kabi USA, LLC — spanning August 2026 through August 2026.

Medications: 22 urgent

The recalls listed below are active notices associated with Fresenius Kabi USA, LLC in the FDA, NHTSA, USDA, and CPSC databases. 2 of these recalls are classified as urgent, meaning the issuing agency has determined a reasonable probability of serious harm. Check the specific lot numbers, model numbers, or production date codes in each notice carefully — a recall typically covers specific production runs, not everything a manufacturer sells.

A manufacturer appearing in the recall database does not indicate an ongoing safety failure. High-volume companies with large product lines naturally appear more frequently. What matters is whether your specific product — identified by lot number, model number, or date code — is included in a recall notice.

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⚠ Active RecallMedications

Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,

Fresenius Kabi USA, LLC

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

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⚠ Active RecallMedications

Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenou

Fresenius Kabi USA, LLC

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

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