Labeling Error Leads Sandoz to Recall the Antibiotic Cefazolin

Sandoz is recalling an additional lot of the antibiotic Cefazolin for Injection, 1 gram per vial, updating its recall from June 27, 2025. Some vials in this lots have been incorrectly labeled as Penicillin G Potassium for Injection, USP, 20 million Units. Sandoz has confirmed that the vials incorrectly labeled as penicillin G potassium actually contain cefazolin.

Administering cefazolin instead of penicillin G potassium could lead to lack of efficacy, less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions and delayed recovery, according to the new recall notice.

Sandoz has received a complaint of administration of the incorrectly labeled product to a patient, but the company has not received any reports of adverse events or injuries related to the product mislabeling.

Both cefazolin and penicillin G potassium belong to the beta-lactam group of antibiotics, but they are indicated for different types of infections, and the spectrum of susceptible organisms also differs.

Cefazolin for Injection USP is used to treat infections, including pneumonia, as well as to prevent infections before and after surgery. Penicillin G Potassium for Injection is indicated to treat serious infections, including septicemia and skin and wound infections. It is also approved 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.

The recalled lots and vials are:

• Cefazolin for Injection, USP (25 by 1 g vials), with a lot number of PG4360 and a carton NDC number of 0781-3451-96. It has an expiration date of November 2027.
• Penicillin G Potassium for Injection, USP, with a lot number of PG4360 and a vial NDC of 0781-6136-94. It has an expiration date of November 2027.
• Cefazolin for Injection, USP (25 by 1 g vials), with a lot number of PG4362 and a carton NDC of 0781-3451-96. It has an expiration date of November 2027.
• Penicillin G Potassium for Injection, USP, with a lot number of PG4362 and a vial NDC of 0781-6136-94. It has an expiration date of November 2027.