Due to Vials Being Potentially Mislabeled as Penicillin G Potassium for Injection

This is an update to the Company Statement issued on June 27, 2025.

FOR IMMEDIATE RELEASE – Princeton, NJ – July 15, 2025 – Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, USP, 20 million Units were included in cartons (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. Sandoz has confirmed that the vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection, USP, 1 gram per vial.

Risk Statement: There is a reasonable probability that the inadvertent administration of cefazolin injection following dosing recommendation of penicillin G potassium injection due to mislabeling may pose serious and potentially life-threatening adverse health consequences, including lack of efficacy leading to less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions, and delayed recovery.

To date, Sandoz has not received any reports of adverse events or injuries related to the product mislabeling. Sandoz has received a complaint of administration of the incorrectly labelled product to a patient.

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