Cefazolin Injection, Solution
FDA Recall NDC 0338-3503
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cefazolin (NDC 0338-3503). A significant event, classified as Class I, was initiated on Jul 24, 2026 by Baxter Healthcare Corporation. The reported reason for this action was: "Presence of Particulate Matter"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate Matter
Jul 24, 2026
Aug 19, 2026
19,032 bags
Recall Profile & Regulatory Data
Event ID
99463
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.
Batch or Lot Expiration Information
Lot# LD175708, Exp Date: 14-Feb-2027.
Affected Packages Involved in this Recall
0338-3508-41Product
0338-3503-41Product
0338-0096-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
