Elevated risk U.S. Food and Drug Administration

Sandoz Cefazolin for Injection, USP, 1 gm vial recall: Vials incorrectly labelled as Penicillin G Potassium for Injection contain

Recall published 1+ years ago

Vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection

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4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Labelling or manufacturing-practice failure

A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

What the notice says: 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.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 15, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Sandoz
Product type
Other food products
Distribution
Nationwide

Products covered by this recall

Cefazolin for Injection, USP, 1 gm vial

What the company announced

“This press release is an update to the company's press release, previously issued on 07/14/2025, to include a new title and additional photos.”

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.

Lots impacted by the voluntary recall and its expansion:

  • Product Name: Cefazolin for Injection, USP (25 by 1g vials) · Vial NDC: 0781-3451-70 · Carton NDC: 0781-3451-96 · Lot Number: PG4360 · Expiration Date: 2027-NOV · Manufacturer: Sandoz GmbH · Distributor: Sandoz Inc
  • Product Name: Penicillin G Potassium for Injection, USP · Vial NDC: 0781-6136-94 · Carton NDC: N/A · Lot Number: PG4360 · Expiration Date: 2027-NOV · Manufacturer: Sandoz GmbH · Distributor: Sandoz Inc
  • Product Name: Cefazolin for Injection, USP (25 by 1g vials) · Vial NDC: 0781-3451-70 · Carton NDC: 0781-3451-96 · Lot Number: PG4362 · Expiration Date: 2027-NOV · Manufacturer: Sandoz GmbH · Distributor: Sandoz Inc
  • Product Name: Penicillin G Potassium for Injection, USP · Vial NDC: 0781-6136-94 · Carton NDC: N/A · Lot Number: PG4362 · Expiration Date: 2027-NOV · Manufacturer: Sandoz GmbH · Distributor: Sandoz Inc

Cefazolin for Injection USP is used for the treatment of infections caused by certain bacteria in many different parts of the body including the treatment of pneumonia. Cefazolin for Injection USP can also be used to prevent infections, before and after surgery. Antibacterial drugs like Cefazolin for Injection USP treat only bacterial infections. They do not treat viral infections. Cefazolin for Injection USP is indicated for adult, elderly, pediatric patients, including newborn term infants.

Penicillin G Potassium for Injection is indicated in the treatment of certain serious infections including septicemia, skin and wound infections. It is also approved for the treatment of 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. To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium for Injection, USP and other antibacterial drugs, Penicillin G Potassium for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Penicillin G Potassium for Injection is indicated for use in adults, adolescents, children, pediatric, newborn infants and preterm infants.

Although both Cefazolin and Penicillin G Potassium belong to the beta-lactam group of antibiotics, they are indicated for different types of infections, and the spectrum of susceptible organisms also differs. Additionally, while the patient populations overlap, each medicine has specific on-label distinct groups, and the dosing regimens may differ, as well.

Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distribution nationwide. Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 265-7409 or by email at [email protected] .

For questions about the recall process, please call Sedgwick at (844) 265-7409 between the hours of 8:00 AM to 5:00 PM Monday - Friday (EST).

Please report any adverse reactions by calling Sandoz at (800) 525-8747. Customer service agents are available from 8:30 AM to 5:00 PM (EST), Monday-Friday, except on national holidays.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Note: The photos represent images of Lot PG4360. Potential mislabeling of Lot PG4362 would appear in a similar manner, except for the lot number printed on the packaging, which would read PG4362.

DISCLAIMER

This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • USP
  • PG4360
  • PG4362

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2027-NOV

NDC number

On the carton and again on the bottle or blister label.

  • 0781-3451-70
  • 0781-3451-96
  • 0781-6136-94

Model or item number

On the rating label, the box or the instruction sheet.

  • USP

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 gram

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Sandoz — A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.
  3. Return the affected pack to the pharmacy for a replacement from a good lot.
  4. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz.

Company contact: Sandoz, Inc. — Consumers: Sedgwick, the Sandoz Reverse Distributor, (844) 265-7409, [email protected] — Media: Jeanne LaCour, Vicki Crafton, 1-609-955-2339, 1-201-213-6338

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Sandoz other food products recalled?

Vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code USP, PG4360, PG4362; best-by date 2027-NOV; model number USP. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The notice says: They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz.

Where was the recalled product sold?

It was distributed nationwide.

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