FDA Class I Recall Issued for Cefazolin for Injection by Sandoz Due to Labeling Mix-Up

Sandoz Inc has issued a voluntary Class I recall of Cefazolin for Injection, USP, 1 gram per vial, a sterile prescription antibiotic used for intramuscular or intravenous administration. This recall involves 208 300 vials distributed nationwide in the US under NDCs 0781-3451-70 (vial) and 0781-3451-96 (carton). Affected lot numbers include PG4360 and PG4362, with an expiration date of November 30, 2027. The recall was initiated on June 27, 2025, following internal findings and public notification via press releases.

The recall stems from a critical labeling error: cartons labeled as Cefazolin were found to contain vials mislabeled as Penicillin G Potassium for Injection, USP, 20 million Units, despite the actual contents being Cefazolin. This labeling discrepancy could result in serious medication errors, particularly in patients with penicillin allergies, or cause inappropriate treatment due to confusion over the drug identity. The US Food and Drug Administration (FDA) classified the recall as Class I, the most serious category, indicating a situation in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Manufactured by Sandoz GmbH and distributed by Sandoz Inc of Princeton, NJ, the product recall remains ongoing as of August 6, 2025. Cefazolin is a first-generation cephalosporin antibiotic indicated for the treatment of a variety of bacterial infections, including those of the respiratory tract, urinary tract, skin, and bones, as well as for surgical prophylaxis. It is commonly used in hospital settings and is a critical component of many treatment protocols, making accurate labeling essential for patient safety and effective clinical use.