FDA Issues Class I Recall for Cefazolin for Injection Due to Penicillin Labeling Mix-Up

The US Food and Drug Administration (FDA) has issued a Class I recall for Cefazolin for Injection, USP, 1 gram per vial, following a labeling mix-up in which vials of Penicillin G Potassium for Injection, USP (20 million units) were mistakenly packed into cartons labeled as Cefazolin. The error affected Lot #PG4360, with an expiration date of November 30, 2027, and involves 208 300 vials distributed nationwide. The product was manufactured by Sandoz GmbH and distributed by Sandoz Inc., based in Princeton, New Jersey. The recall was voluntarily initiated and publicly announced via press release on June 27, 2025.

This recall has been classified as Class I, the most serious recall level, indicating that use of the product could result in serious injury or death. This labeling error presents a significant risk, particularly to patients with penicillin allergies, who could unknowingly receive a beta-lactam antibiotic that may trigger life-threatening anaphylaxis. The recalling firm, Sandoz Inc., issued a press release to alert health care providers and distributors of the potential hazard and advised immediate removal of the affected lot from inventory.

Cefazolin is a first-generation cephalosporin antibiotic indicated for the treatment of bacterial infections, including respiratory tract, urinary tract, skin, bone, and joint infections, and perioperative prophylaxis. The mix-up with Penicillin G Potassium, though also an antibiotic, is clinically distinct and carries a high-risk safety concern in penicillin-allergic patients.