Cefazolin Injection, Powder, For Solution
FDA Recall NDC 0781-3450
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Cefazolin (NDC 0781-3450). A significant event, classified as Class I, was initiated on Jun 27, 2025 by Sandoz Inc. The reported reason for this action was: "Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin"
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
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Jun 27, 2025
Jul 09, 2025
208,300 vials
Recall Profile & Regulatory Data
Event ID
97140
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Batch or Lot Expiration Information
Lot# PG4360, PG4362, Exp. 11/30/2027
Affected Packages Involved in this Recall
0781-3450-70Product
0781-3450-95Product
0781-3451-70Product
0781-3451-96Product
0781-3451-95Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
8 vials
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70
Batch or Lot Expiration Information
Lot# JZ9830
Affected Packages Involved in this Recall
0781-3450-70Product
0781-3450-95Product
0781-3451-70Product
0781-3451-96Product
0781-3451-95Product
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.
