Quick answers
- What is Sodium acetate used for?
- The FDA-approved label (Sodium Acetate, Hospira, Inc., March 26, 2026) says: “Sodium Acetate Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium acetate have a boxed warning?
- The label we quote has no boxed warning, but 1 of 12 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Sodium acetate?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 27, 2026). Ask your pharmacist about alternatives.
- Has Sodium acetate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 4, 2022 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Sodium acetate?
- 6 companies list prescription products of Sodium acetate in the FDA NDC Directory, including Hospira, Inc., Milla Pharmaceuticals Inc. and Amneal Pharmaceuticals Private Limited.
What Sodium acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sodium Acetate Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
— FDA label: Sodium Acetate, Hospira, Inc., effective March 26, 2026. Read the full label on DailyMed →
The FDA has 12 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 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate · Injection · Solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 15 in the FDA NDC Directory |
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.
- Hospira, Inc.4 products
- Milla Pharmaceuticals Inc.4 products
- Amneal Pharmaceuticals Private Limited3 products
- Hikma Pharmaceuticals USA Inc.3 products
- Somerset Therapeutics, LLC2 products
- Fresenius Kabi USA, 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 |
|---|---|---|---|
| NDA018893 SODIUM ACETATE | Hospira | May 4, 1983 | 17, latest September 2, 2014 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2003: Manufacturing (CMC) |
Generic approvals (5)
- ANDA206687Fresenius Kabi USA · October 30, 2017
- ANDA214805Milla Pharms · May 4, 2021
- ANDA216920Hikma · March 15, 2024
- ANDA218469Amneal · August 8, 2025
- ANDA219826Somerset Theraps LLC · September 18, 2025
Shortage status
Current shortage · updated October 27, 2026 · first posted February 3, 2016
| Product | Sodium Acetate, Injection, 164 mg/1 mL (NDC 70069-047-25) |
|---|---|
| Availability | Available |
| Company | Somerset Therapeutics, 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.
-
March 4, 2022 · Class I · Terminated · D-0750-2022
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zuri — Fresenius Kabi USA, LLC
-
February 26, 2013 · Class II · Terminated · D-316-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73 — Hospira 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) | 237371, 312965, 1859490 |
|---|---|
| SPL set ID of the quoted label | ce9a7469-c4ba-4f60-8f7a-47ef0974316e |
| FDA labels (SPL) | 12 |
| FDA applications | NDA018893, 5 ANDA |
| Active ingredients (FDA) | SODIUM ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sodium Acetate, Hospira, Inc., effective March 26, 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 →