Quick answers
- What is Cefepime used for?
- The FDA-approved label (Cefepime Hydrochloride and Dextrose, B. Braun Medical Inc., April 7, 2026) says: “Cefepime for Injection and Dextrose Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cefepime have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cefepime?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated February 10, 2026). Ask your pharmacist about alternatives.
- Has Cefepime been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started November 21, 2013 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Cefepime?
- 10 companies list prescription products of Cefepime in the FDA NDC Directory, including Apotex Corp., WG Critical Care, LLC and Hikma Pharmaceuticals USA Inc..
What Cefepime is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cefepime for Injection and Dextrose Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms …
— FDA label: Cefepime Hydrochloride and Dextrose, B. Braun Medical Inc., effective April 7, 2026. Read the full label on DailyMed →
The FDA has 13 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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.
0 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, solution |
|---|---|
| Route | Intravenous · Intramuscular |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Cefepime Hydrochloride and Dextrose |
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.
- Apotex Corp.6 products
- WG Critical Care, LLC4 products
- Hikma Pharmaceuticals USA Inc.4 products
- Qilu Pharmaceutical Co., Ltd.3 products
- Fresenius Kabi USA, LLC2 products
- Hospira, Inc.2 products
- Sagent Pharmaceuticals2 products
- B. Braun Medical Inc.2 products
- Baxter Healthcare Corporation1 product
- Samson Medical Technologies LLC1 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 |
|---|---|---|---|
| NDA050817 CEFEPIME IN PLASTIC CONTAINER | Baxter Hlthcare | August 5, 2008 | 7, latest June 25, 2026 2026: Labeling · 2025: Labeling · 2020: Labeling |
| NDA050821 CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | B Braun | May 6, 2010 | 5, latest April 7, 2026 2026: Labeling · 2022: Labeling · 2015: Labeling |
Generic approvals (4)
- ANDA065441Acs Dobfar · March 20, 2008
- ANDA203704Qilu Antibiotics · February 1, 2016
- ANDA209408Samson Medcl · August 21, 2018
- ANDA214402Hikma · May 22, 2024
Shortage status
To be discontinued · updated February 10, 2026 · first posted February 10, 2026
| Product | Cefepime Hydrochloride, Injection, 1 g (NDC 63323-326-20) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
November 21, 2013 · Class I · Terminated · D-1267-2014
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11 — B. Braun Medical Inc
-
October 15, 2013 · Class I · Terminated · D-1054-2014
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11 — 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
| RxCUI (RxNorm) | 1665088, 1665093, 1665097, 2058953 |
|---|---|
| SPL set ID of the quoted label | 57517a0e-ec1b-4605-a7cc-7e3801158ec9 |
| FDA labels (SPL) | 13 |
| FDA applications | NDA050817, NDA050821, 4 ANDA |
| Active ingredients (FDA) | CEFEPIME |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cefepime Hydrochloride and Dextrose, B. Braun Medical Inc., effective April 7, 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 →