Prescription medicine
Potassium acetate
Potassium acetate is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the potassium acetate FDA label on DailyMed (effective April 27, 2026, Hospira, Inc.); the NDA 18896 record on Drugs@FDA; every potassium acetate label on DailyMed.
Highlights of the record
FDA label of April 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePotassium Acetate Injection, USP, 40 mEq is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake.
Forms and strengths
- 3.93 g/20ml
- 196 mg/ml
- 196.3 mg/ml
- 200 meq/100ml
Injection (solution) (concentrate); injection.
On the market
- Earliest approval on file
- July 20, 1984 Potassium Acetate, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first December 29, 2015; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2020 0 Class I among all firms' recalls; latest May 5, 2020; 1 more by firms not listed as its makers
- FAERS reports
- 1,437 through July 30, 2026
What is potassium acetate used for?
From the label: indications and usagePotassium Acetate Injection, USP, 40 mEq is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia 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 pharmacologic class: Osmotic Laxative and Potassium Salt.
Source: FDA drug label (Potassium Acetate), Hospira, Inc., effective April 27, 2026 (SPL set c7eabefd-2781-439b-b8f4-cb3ea25a4720), via openFDA; the full label on DailyMed
Is there a generic for potassium acetate?
The FDA approved the first generic potassium acetate on December 29, 2015. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists potassium acetate from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has potassium acetate been recalled?
The FDA's Enforcement Report lists 2 recalls naming potassium acetate since 2020: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of potassium acetate and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 28, 2023 | Class II | Central Admixture Pharmacy Services, Inc. not a listed maker | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. |
| May 5, 2020 | Class III | Exela Pharma Sciences LLC | Short Fill |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the potassium acetate label say about other medicines?
The potassium acetate label names no other medicine on this site. The labels of 1 other medicine name potassium acetate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Potassium Acetate), Hospira, Inc., effective April 27, 2026 (SPL set c7eabefd-2781-439b-b8f4-cb3ea25a4720), via openFDA; the full label on DailyMed
What do FAERS reports show for potassium acetate?
The FDA Adverse Event Reporting System holds 1,437 reports that list potassium acetate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 155 are coded as a death and 549 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Potassium acetate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other