COMPANY ANNOUNCEMENT
BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason DescriptionParticulate matter (cardboard) found in the solution.
- Company Name:
- Baxter International Inc.
- Brand Name:
-
Brand Name(s)Baxter
- Product Description:
-
Product DescriptionCefazolin in Dextrose Injection
Company Announcement
July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter found in the solution identified as cardboard.
Risk Statement: The use of the defective product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells). To date, Baxter has not received any reports of adverse events related to this issue.
Affected Product:
This product is used intravenously to treat bacterial infections or prevent them during surgery
| Product Code | Product Description | Lot Number | Expiration Date | NDC Number |
|---|---|---|---|---|
| 2G3508 | Cefazolin in Dextrose Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix | LD175708 | 14-Feb-2027 | 0338-3508-41 |
The affected lots can be identified by locating the lot number and expiration date on the front of the product package and the label attached to the carton, as shown in the images below.
The impacted product was distributed from 3/25/2025 to 6/30/2025 in the United States.
Customers should immediately discontinue use of and return all affected units in accordance with their facility’s process. Baxter is contacting customers with instructions on how to identify and return the impacted product.
For general questions regarding this communication, please contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The United States Food and Drug Administration (FDA) has been notified of this action.
Company Contact Information
- Consumers:
- (888) 229-0001
- Media:
- Brenna Byrne
- (224) 948-5353
- media@baxter.com
