Use caution Drug recall · FDA · Published June 27, 2025

Sandoz Cefazolin Injection Recall: Label Mix-Up Risk

Sandoz recalls Cefazolin injections due to label mix-up with penicillin vials. Affected lots may contain incorrect medication. Stop using if unsure.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0569-2025Drug Sandoz ›

Sandoz — official photo 1 — Official FDA recall photos · click to enlarge

Use caution until it’s fixed

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

Take action

Contact the company

Recalling firmSandoz Inc100 College Rd W · Princeton, NJ 08540-6604

✎ GovInfoNow plain-language explainer

Sandoz is recalling Cefazolin injections that were mislabeled with penicillin vials. This mix-up could lead to incorrect medication being administered, which is dangerous for patients. Read more at govinfonow.com/recall/32008-sandoz-cefazolin-injection-recall-label-mix-up-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32008-sandoz-cefazolin-injection-recall-label-mix-up-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0569-2025

Cite this page

“Sandoz Cefazolin Injection Recall: Label Mix-Up Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32008-sandoz-cefazolin-injection-recall-label-mix-up-risk. Based on FDA recall #D-0569-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0569-2025%22&limit=1).

The FDA announced on June 27, 2025, that Sandoz Inc is recalling Cefazolin for Injection, USP, 1 gram per vial due to a labeling mix-up hazard. The recall affects 208,300 vials distributed nationwide.

How to tell if you have it

Brand: Sandoz
Product: Cefazolin for Injection, USP, 1 gram per vial
NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton)
Lot codes: PG4360, PG4362
Expiration date: 11/30/2027

The hazard

Cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials actually contained Cefozalin.

Context

GovInfoNow's records show Sandoz Inc has 29 other recalls on record since 2013-10-09. Other recent recalls include Sandoz Focalin XR 5mg Capsules (2026-06-01), Sandoz Cyclophosphamide Injection (2025-09-05), and Sandoz Ciprofloxacin Otic Suspension (2025-08-13). Other recent recalls of similar products include American Regent Levocarnitine Injection (2026-04-16), Sun Pharmaceutical Perampanel 6mg Tablets (2026-06-17), and Ajanta Pharma Aripiprazole Tablets 30mg (2026-05-27).

How to tell if you have this one

Check the vial label for 'Cefazolin' or 'penicillin G potassium'. The product was sold with NDC numbers 0781-3451-70 (vial) and 0781-3451-96 (carton).

Brand
Sandoz
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity	NDC
D-0569-2025	Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).; Lot # PG4360, PG4362, Exp. 11/30/2027	208,300 vials	0781-3450-70, 0781-3450-95, 0781-3451-70, 0781-3451-96, 0781-3451-95
D-0570-2025	Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.; Lot # PG4360, PG4362, Exp. 11/30/2027	unknown	0781-6135-94, 0781-6135-95, 0781-6136-94

Based on the official FDA remedy

What to do — step by step

Check Label
Look for the label indicating 'Cefazolin' on the vial. If it says 'penicillin G potassium', it is mislabeled.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 12 days after the firm started it.

Jun 27, 2025Firm started the recall
Jul 9, 2025Published in FDA’s Enforcement Report
Aug 6, 2025FDA classified it Class I

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a specific lot number I should check?

Yes, the affected lots are PG4360 and PG4362, expiring November 30, 2027.

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Link to this recall

<a href="https://govinfonow.com/recall/32008-sandoz-cefazolin-injection-recall-label-mix-up-risk">Sandoz Cefazolin Injection Recall: Label Mix-Up Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0569-2025 (June 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0569-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.