Elevated risk U.S. Food and Drug Administration

Sandoz Cefazolin for Injection, USP, 1 gm vial recall: Potential Presence of Penicillin G Potassium Injection Vial

Recall published 1+ years ago

Potential Presence of Penicillin G Potassium Injection Vial

Sandoz Prescription & OTC drugs — recalled prescription & otc drugsSandoz Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Risk Statement: There is a reasonable probability that the inadvertent administration of penicillin G potassium injection, instead of intended cefazolin injection, 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, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment, and delayed recovery.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
June 27, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Sandoz
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Cefazolin for Injection, USP, 1 gm vial

What the company announced

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial . This single lot is being recalled due to a customer complaint indicating that four (4) Penicillin G Potassium for Injection, USP, 20 million Units labelled vials were incorrectly included in a carton (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product.

Risk Statement: There is a reasonable probability that the inadvertent administration of penicillin G potassium injection, instead of intended cefazolin injection, 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, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment, and delayed recovery.

To date, Sandoz has not received any reports of adverse events or injuries related to this recall. Sandoz has received a complaint of inadvertent administration of the incorrect product to a patient.

  • 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

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) 491-7872 or by email at [email protected] .

For questions about the recall process, please call Sedgwick at (844) 491-7872 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 also 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 1

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm 2 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.

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 8 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

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 Drug safety

Sandoz — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Sandoz Inc. — Consumers: Sedgwick, 844-491-7872, [email protected] — Media: Jeanne LaCour, 609-955-2339

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 prescription & otc drugs recalled?

Potential Presence of Penicillin G Potassium Injection Vial Risk Statement: There is a reasonable probability that the inadvertent administration of penicillin G potassium injection, instead of intended cefazolin injection, 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, cardiac arrhythmias resulting from high potassium especially in patients with kidney impairment…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code USP, PG4360; 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?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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