Class IOngoing

Cefazolin for Injection recall

FDA recall D-0569-2025 · initiated Jun 27, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

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

Details

Product: 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).
Recalling company: Sandoz Inc
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Jun 27, 2025
FDA report date: Jul 9, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0569-2025 ↗

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