Quick answers
- What is Cefazolin used for?
- The FDA-approved label (Cefazolin, WG Critical Care, LLC, February 27, 2026) says: “Cefazolin for Injection is a cephalosporin antibacterial indicated for perioperative prophylaxis in adult patients. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefazolin have a boxed warning?
- The label we quote has no boxed warning, but 1 of 28 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Cefazolin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cefazolin been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started July 24, 2026 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Cefazolin?
- 16 companies list prescription products of Cefazolin in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., WG Critical Care, LLC and Apotex Corp..
What Cefazolin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cefazolin for Injection is a cephalosporin antibacterial indicated for perioperative prophylaxis in adult patients. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. …
— FDA label: Cefazolin, WG Critical Care, LLC, effective February 27, 2026. Read the full label on DailyMed →
The FDA has 28 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 28 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Powder, for solution · Injection, solution · Solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous · Intramuscular · Parenteral |
| Prescription products | 47 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cefazolin sodium 1 g injection, powder, for solution | Generic | $1.07 per unit |
| cefazolin sodium 1 g/3 mL powder, for solution | Generic | $1.07 per unit |
| cefazolin sodium 330 mg/mL injection, powder, for solution | Generic | $1.07 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.8 products
- WG Critical Care, LLC6 products
- Apotex Corp.6 products
- Civica, Inc.3 products
- Fresenius Kabi USA, LLC3 products
- Baxter Healthcare Corporation3 products
- Henry Schein, Inc.3 products
- B. Braun Medical Inc.3 products
- Sandoz Inc3 products
- Samson Medical Technologies, L.L.C.2 products
- Medical Purchasing Solutions, LLC2 products
- A-S Medication Solutions1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- Proficient Rx LP1 product
- Direct_Rx1 product
- ProPharma Distribution1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050779 CEFAZOLIN AND DEXTROSE | B Braun | July 27, 2000 | 16, latest January 17, 2025 2025: Labeling · 2024: Efficacy · 2021: Labeling |
| NDA207131 CEFAZOLIN IN DEXTROSE | Baxter Hlthcare Corp | August 7, 2015 | 8, latest August 31, 2026 2026: Labeling · 2024: Efficacy · 2024: Efficacy |
| NDA211413 CEFAZOLIN SODIUM | Hq Spclt Pharma | May 8, 2023 | 2, latest February 13, 2026 2026: Efficacy · 2024: Manufacturing (CMC) |
| NDA216109 CEFAZOLIN SODIUM | Hikma | October 7, 2022 | 1, latest December 18, 2024 2024: Efficacy |
Generic approvals (8)
- ANDA062831Sandoz · December 9, 1988
- ANDA065047Hikma Farmaceutica · September 18, 2001
- ANDA065143Hikma Farmaceutica · October 18, 2004
- ANDA065141Samson Medcl · November 29, 2006
- ANDA065303Acs Dobfar · October 22, 2008
- ANDA065306Acs Dobfar · October 22, 2008
- ANDA203661Qilu Antibiotics · December 28, 2015
- ANDA209217Qilu Antibiotics · October 17, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 24, 2026 · Class I · Ongoing · D-0787-2026
Presence of Particulate Matter
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 6001 — Baxter Healthcare Corporation
-
June 27, 2025 · Class I · Ongoing · D-0569-2025
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
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) — Sandoz Inc
-
April 13, 2022 · Class II · Terminated · D-1118-2022
cGMP deviations: Temperature abuse
Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3105-11 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1117-2022
cGMP deviations: Temperature abuse
Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3103-11 — Mckesson Medical-Surgical Inc. Corporate Office
-
March 15, 2021 · Class II · Terminated · D-0564-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70 — Cardinal Health Inc.
-
November 21, 2013 · Class I · Terminated · D-1269-2014
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11 — B. Braun Medical Inc
-
November 21, 2013 · Class I · Terminated · D-1268-2014
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-1 — B. Braun Medical Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefazolin, WG Critical Care, LLC, effective February 27, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →