The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.
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FDA announced on June 27, 2025, that Sandoz, Inc. is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial after customers complained that four penicillin G potassium for injection, USP, 20 million units labeled vials were incorrectly included in a carton of Cefazolin for Injection vials (1). While the company states it has not received any reports of adverse events associated with the recall, they did receive one complaint of the wrong product being given to a patient.
The impacted lot number is PG4360, vial national drug code (NDC) number 0781-3451-70, with an expiration date of 2027-NOV (1). The lot was manufactured by Sandoz GmbH and distributed by Sandoz Inc. The vials that were incorrectly included have the vial NDC 0781-6136-94 and an expiration date of 2027-NOV.
Cefazolin for injection USP is indicated for the treatment and/or prevention of bacterial infections in different parts of the body in adults, the elderly, and children (1). Penicillin G potassium for injection treats certain serious infections, such as septicemia, skin infections, and wound infections, and can be used to treat diphtheria, community-acquired pneumonia, peritonitis, meningitis/brain abscesses, osteomyelitis, infections of the genital tract, anthrax, tetanus, gas gangrene, listeriosis, pasteurellosis, rat bite fever, fusospirochetes, actinomycosis, complications in gonorrhea and syphilis, and Lyme. It should be used to only treat or prevent infections caused by susceptible bacteria to reduce the chance of drug-resistant bacterial from developing.
According to an FDA press release (1), the two antibiotics have different indications despite being part of the same beta-lactam group of antibiotics and having overlapping patient populations. The dosing regimens for each may also differ.
Administration of penicillin G potassium injection instead of cefazolin injection may have life-threatening consequences that include lack of efficacy resulting in less than optimal treatment of severe infections, antibiotic resistance, allergic reactions, drug interactions, and cardiac arrhythmias caused by high potassium.
Sandoz is asking customers to return the recalled product, which was shipped to select wholesalers for nationwide distribution. The company recommends providers stop using the product immediately. Adverse events may be reported to FDA through its MedWatch Adverse Event Reporting program.
In other Sandoz news, the company broke ground on a new facility in Slovenia in July that will produce injectable products for both existing and upcoming biosimilars. The project adds $440 million to a $1.1 billion investment the company has planned through 2029.
"Biosimilars is the fastest-growing segment of our pipeline as the need of patients and healthcare systems for these critical medicines continues to grow rapidly,” Richard Saynor, chief executive officer of Sandoz, said in a press release (2). “As the global leader in the field, we are investing to meet rapidly growing patient demand. With a commitment of over US$1.1 billion, we are proud to significantly expand our biosimilar manufacturing capacity in Europe as Slovenia’s largest direct foreign investor. This is another major step that will position Sandoz uniquely to capitalize on the unprecedented biosimilars market opportunity of the next decade."
"Our investment in biomanufacturing in the heart of Europe marks another important milestone in building our own independent manufacturing network—one that enhances our control, resilience and agility across the global supply chain,” Glenn Gerecke, chief manufacturing and supply officer at Sandoz, said in the release. “We recognize the strategic value Slovenia brings for us as a company: a highly skilled talent pool in natural sciences and engineering; a central location with world-class logistics infrastructure; cost-competitive production; and a stable, innovation-driven environment closely connected to academia and research."
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