Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by S
Summary
The FDA issued a Class I for Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Int by Sandoz Inc. Reason: Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, US.
Details
Source
Drug Recall
External ID
D-0569-2025
Action Date
2025-07-09
Status
Ongoing
Category
drug
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).
Lot/Code Info: Lot # PG4360, PG4362, Exp. 11/30/2027
Quantity Affected: 208,300 vials
Reason for Recall
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
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-27
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 59 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Sandoz Inc has 19 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sandoz Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sandoz Inc have FDA actions?
Sandoz Inc has 19 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0569-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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