Quick answers
- What is Ampicillin sodium and sulbactam sodium used for?
- The FDA-approved label (Unasyn, Roerig, July 10, 2026) says: “UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ampicillin sodium and sulbactam sodium have a boxed warning?
- The label we quote has no boxed warning, but 1 of 27 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Ampicillin sodium and sulbactam sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ampicillin sodium and sulbactam sodium been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started May 29, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ampicillin sodium and sulbactam sodium?
- 13 companies list prescription products of Ampicillin sodium and sulbactam sodium in the FDA NDC Directory, including Eugia US LLC, Meitheal Pharmaceuticals Inc. and WG Critical Care, LLC.
What Ampicillin sodium and sulbactam sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. …
— FDA label: Unasyn, Roerig, effective July 10, 2026. Read the full label on DailyMed →
The FDA has 27 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 27 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution |
|---|---|
| Route | Intravenous · Intramuscular |
| Prescription products | 37 in the FDA NDC Directory |
| Brand names | Unasyn |
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.
- Eugia US LLC8 products
- Meitheal Pharmaceuticals Inc.6 products
- WG Critical Care, LLC4 products
- NorthStar Rx LLC3 products
- Avenacy, LLC3 products
- Onesource Specialty Pharma Limited3 products
- Armas Pharmaceuticals Inc.3 products
- Hikma Pharmaceuticals USA Inc.3 products
- Sagent Pharmaceuticals3 products
- Roerig3 products
- Hospira, Inc.2 products
- Medical Purchasing Solutions, LLC1 product
- Civica, Inc.1 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 |
|---|---|---|---|
| NDA050608 UNASYN | Pfizer | December 31, 1986 | 29, latest November 5, 2025 2025: Labeling · 2025: Labeling · 2024: Labeling |
Generic approvals (12)
- ANDA065188Hq Speclt Pharma · November 25, 2005
- ANDA065222Acs Dobfar Spa · November 29, 2005
- ANDA065310Sandoz · July 25, 2006
- ANDA065314Acs Dobfar Spa · November 27, 2006
- ANDA065406Acs Dobfar · December 22, 2009
- ANDA065403Acs Dobfar · December 23, 2009
- ANDA090339Eugia Pharma Speclts · September 20, 2010
- ANDA090340Eugia Pharma Speclts · September 20, 2010
- ANDA090349Eugia Pharma Speclts · September 20, 2010
- ANDA201024Onesource Specialty · April 7, 2014
- ANDA202197Onesource Specialty · April 7, 2014
- ANDA201406Antibiotice · December 7, 2015
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.
-
May 29, 2020 · Class II · Terminated · D-1306-2020
Presence of Particulate Matter: particulate matter identified after reconstitution.
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-8 — Pfizer Inc.
-
May 1, 2018 · Class I · Terminated · D-0866-2018
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20. — AuroMedics Pharma LLC
-
January 2, 2018 · Class I · Terminated · D-0339-2018
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20 — Aurobindo Pharma Ltd.
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) — Unasyn, Roerig, effective July 10, 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 →