Fresenius Kabi

Fresenius Kabi recalled one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after discovering the product contains glass particles. The affected lot was distributed nationwide to hospitals, clinics, and distributors.

Fresenius Kabi recalled one lot of Morphine Sulfate Injection 2 mg/1 mL prefilled syringes due to a labeling error. Packages labeled as morphine may actually contain Dilaudid (hydromorphone), a different and more potent opioid. Using the wrong medication could cause serious respiratory problems or death, especially in patients not used to opioids or those with lung disease.

Hair was found in Xylocaine (lidocaine HCl Injection, USP) 1% vials distributed nationwide. The affected product is Lot #6133986 with expiration date 02/2029. No injuries have been reported.

Hair was found in vials of Xylocaine (lidocaine HCl Injection, USP) 1% supplied by Fresenius Kabi. The affected product is a multiple-dose vial medication used for local anesthesia. This contamination could pose a risk if the injection is administered without detection.

Hair was found in Naropin (ropivacaine hydrochloride) injection vials used for local anesthesia. The affected product is the 0.5% concentration in 20 mL single-dose vials. Approximately 92,600 vials from Lot #6133436 (expiration 10/2028) were distributed nationwide.

Hair was found in Fresenius Kabi Lidocaine HCl Injection vials (2%, 20 mg per mL). This affects 181,225 vials nationwide with lot number 6133801 and an expiration date of January 2028. No injuries have been reported.

Hair was found in some vials of Fresenius Kabi glycopyrrolate injection. The affected product is a prescription medication used during anesthesia and medical procedures. Two lots distributed nationwide are involved.

Fresenius Kabi USA is recalling specific batches of epinephrine injection due to failed impurity and degradation specifications. The affected vials may not meet required purity standards. No injuries have been reported.

Fresenius Kabi USA is recalling a specific batch of 5% Dextrose Injection due to concerns that the product may not meet sterility standards. This injectable solution is used in medical settings to deliver fluids and glucose to patients. The affected batch (6402165, expiring 05/30/2028) was distributed nationwide.

Fresenius Kabi is recalling specific batches of 5% Dextrose Injection because the company cannot guarantee the product is sterile. This intravenous solution is used in hospitals and medical settings. The affected batches have expiration dates of February 28, 2027.

Fresenius Kabi is recalling a specific batch of 5% Dextrose Injection due to lack of assurance of sterility. The affected product is in 50 mL freeflex bags. This intravenous medication was distributed nationwide, including Alaska and Puerto Rico.

Fresenius Kabi USA is recalling a specific batch of 0.9% Sodium Chloride Injection (a sterile saline solution used in medical settings) because the manufacturer cannot guarantee it remained sterile during production. The affected batch (24EU10010) was distributed nationwide, including Alaska and Puerto Rico.

Fresenius Kabi is recalling specific batches of 0.9% sodium chloride injection (saline) in 1,000 mL freeflex bags due to lack of assurance of sterility. The affected batches were distributed nationwide, including Alaska and Puerto Rico. No injuries have been reported.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection (saline solution) used in medical settings because the manufacturer cannot guarantee the product is sterile. The affected batches were distributed nationwide. No injuries have been reported so far.

Lack of Assurance of Sterility

Fresenius Kabi USA is recalling specific batches of 0.9% Sodium Chloride Injection (a sterile saline solution) because the manufacturer cannot guarantee the product is free from contamination. The affected batches were distributed nationwide, including Alaska and Puerto Rico, between now and June 2027.

Fresenius Kabi USA is recalling specific batches of 0.9% Sodium Chloride Injection (saline) because the manufacturer cannot confirm the product is sterile. Sterility is critical for injectable medications. The affected batches have expiration dates of October 31, 2026, or November 30, 2026.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection due to a lack of assurance that the product is sterile. This injectable solution is used in medical settings and could pose a risk if contaminated. No injuries have been reported to date.

Fresenius Kabi USA is recalling multiple batches of 0.9% Sodium Chloride Injection (saline solution) used for medical purposes because the manufacturer cannot guarantee the product is sterile. The affected batches were distributed nationwide, Alaska, and Puerto Rico. No injuries have been reported.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection (saline) in 100 mL bags due to lack of assurance of sterility. The affected batches were distributed nationwide, including Alaska and Puerto Rico. No injuries have been reported.

Fresenius Kabi is recalling specific batches of 0.9% Sodium Chloride Injection because the manufacturer cannot guarantee these vials are sterile. This injectable medication is used in hospitals and clinical settings. No injuries have been reported.

Fresenius Kabi is recalling one batch of 0.45% sodium chloride injection (saline solution) used in hospitals and medical facilities because the manufacturer cannot guarantee the product is sterile. The affected batch is #6402413 with an expiration date of 02/29/2028. No infections or injuries have been reported so far.

Fresenius Kabi Compounding has recalled vancomycin HCl 2-gram doses mixed in sodium chloride solution due to concerns that sterility cannot be assured. The affected lots were distributed nationwide. This is a serious issue because non-sterile injectables can cause life-threatening infections.

Fresenius Kabi Compounding issued a recall of vancomycin HCl 1.5 grams in 500 mL sodium chloride solution due to lack of assured sterility. The affected lot (C274-000049628, expiring May 3, 2026) was distributed nationwide to healthcare facilities. No injuries have been reported.

Fresenius Kabi Compounding has recalled multiple lots of thiamine HCl 500 mg injection because the manufacturer cannot confirm the product is sterile. This injectable medication was distributed nationwide. The recall affects 10,548 bags with expiration dates between February and May 2026.

Fresenius Kabi Compounding has recalled five specific lots of ketamine HCl injection (10 mg per mL) distributed nationwide because the manufacturer cannot confirm the product remains sterile. The affected lots were produced between February and April 2026.

Fresenius Kabi Compounding has recalled acyclovir sodium 200 mg IV injection bags because the manufacturer cannot guarantee the product is sterile. The affected bags were produced by Fagron Sterile Services and have lot number C274-000049124 with an expiration date of February 28, 2026. No infections or injuries have been reported so far.

Fresenius Kabi is issuing a recall for the Ivenix Infusion System (IIS) with LVP Software version 5.10.2 and earlier. The manufacturer is emphasizing instructions for LVP duration programming in the device manual to ensure proper use. No injuries have been reported.

Fresenius Kabi has recalled software version 5.10.1 and earlier for the Ivenix Infusion System due to anomalies that could cause serious patient harm. The affected software is used to control the delivery of fluids to patients in medical settings. About 30 units have been distributed across multiple U.S. states.

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.