The Recall Desk

Manufacturer

Fresenius Kabi USA, LLC

95 recalls in our database name Fresenius Kabi USA, LLC as the manufacturing or recalling firm.

What the numbers show

Total
95
Critical
8
Severe
34
Most recent
2026-09-02

Of the 95 recalls from Fresenius Kabi USA, LLC we have scored against our rubric, 8 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 34 (36%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 95

  • SevereFDA (Drugs)·D-0750-2022·2022-03-30

    Fresenius Kabi Sodium Acetate Injection Recalled for Particulate Matter

    Fresenius Kabi USA is recalling sodium acetate injection due to the presence of particulate matter composed of carbon, oxygen, iron, and trace elements in multiple lots distributed nationwide.

    Product
    SODIUM ACETATE — SODIUM ACETATE (SODIUM ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0856-2021·2021-10-06

    Morphine Sulfate Injection Recalled Due to Defective Vials

    Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0651-2021·2021-07-14

    Xylocaine Lidocaine Injection Recalled for Low Epinephrine Assay Results

    Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 injection vials nationwide due to low out-of-specification results for epinephrine assay.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2021·2020-12-30

    Fresenius Kabi Recalls Sensorcaine Due to Low Epinephrine Levels

    Fresenius Kabi is recalling 4,411 trays of Sensorcaine (Bupivacaine HCl and Epinephrine) because the epinephrine component tested below specification.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0120-2021·2020-12-16

    Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination

    Fresenius Kabi is recalling 13,525 bottles of Dexmedetomidine HCl Injection due to cross-contamination with trace amounts of lidocaine.

    Product
    Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1537-2020·2020-09-02

    Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination

    Fresenius Kabi is recalling specific lots of Dexmedetomidine HCl Injection due to trace amounts of lidocaine contamination.

    Product
    Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1391-2020·2020-07-22

    Fresenius Kabi Recalls Fosaprepitant Injection Due to Labeling Error

    Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection because carton labels and product inserts incorrectly state the amount of the excipient edetate disodium (EDTA).

    Product
    FOSAPREPITANT — FOSAPREPITANT (FOSAPREPITANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0299-2019·2018-12-12

    Fresenius Kabi Recalls Sodium Chloride Vials Due to Incorrect Latex Labeling

    Fresenius Kabi is recalling 1,312,350 vials of Sodium Chloride Injection because labels incorrectly state the stoppers do not contain natural rubber latex.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0426-2018·2018-02-07

    Fresenius Kabi Recalls Vecuronium Bromide Vials Due to Impurity Failure

    Fresenius Kabi USA is recalling 35,620 vials of Vecuronium bromide for Injection due to an out-of-specification result for a related compound.

    Product
    Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0647-2017·2017-04-12

    Fresenius Kabi Recalls Subpotent Fluphenazine Decanoate Injection Vials

    Fresenius Kabi USA is recalling 118,224 vials of Fluphenazine Decanoate Injection because the drug was found to be subpotent.

    Product
    Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2017·2017-02-08

    Fresenius Kabi Recalls Midazolam Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Midazolam Injection because they failed impurities and degradation specifications.

    Product
    MIDAZOLAM — MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2016·2016-06-22

    Fresenius Kabi Recalls Sensorcaine Due to Glass Particulate Matter

    Fresenius Kabi is recalling specific lots of Sensorcaine injection because glass particulate matter was found in the sterile product.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0867-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi USA is recalling Octreotide Acetate Injection vials because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0819-2016·2016-04-20

    Fresenius Kabi Recalls Cisatracurium Vials Due to Labeling Error

    Fresenius Kabi is recalling 94,560 vials of Cisatracurium Besylate Injection because the carton labels incorrectly state the product is preservative-free.

    Product
    CISATRACURIUM — CISATRACURIUM (CISATRACURIUM BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0818-2016·2016-04-20

    Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity

    Fresenius Kabi USA, LLC is recalling Haloperidol Decanoate Injection due to an impurity out-of-specification result. The recall affects 48,210 units distributed nationwide and in Puerto Rico.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Fresenius Kabi

company based in Bad Homborg, Germany; offers health products for the critically and chronically ill.

Country
Germany
Founded
1999
Parent company
Fresenius SE & Co. KGaA

Official website

Source: Wikidata (Q1455670), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.