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Class I · Most seriousActive recall

Cefazolin

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # PG4360, PG4362, Exp. 11/30/2027
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySandoz GmbH for Sandoz Inc. Princeton, NJ 08540
Brand nameCEFAZOLIN
Generic nameCEFAZOLIN
Active ingredient(s)CEFAZOLIN SODIUM
Distributed by / forSandoz Inc
NDC0781-3451-96
Show the full FDA record
Full product labelCefazolin 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).
Recalling firmSandoz Inc
DistributionNationwide in the USA
Quantity208,300 vials
Recall initiated2025-06-27
Report date2025-07-09
Recall completed
Recall numberD-0569-2025
ClassificationClass I
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.