Quick answers
- What is Potassium chloride used for?
- The FDA-approved label (Klor-Con, Upsher-Smith Laboratories, LLC, July 14, 2025) says: “Klor-Con is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Potassium chloride have a boxed warning?
- The label we quote has no boxed warning, but 1 of 194 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Potassium chloride?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated November 21, 2025). Ask your pharmacist about alternatives.
- Has Potassium chloride been recalled?
- FDA enforcement reports list 13 recalls of products of this medicine; the newest started October 29, 2025 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Potassium chloride?
- 73 companies list prescription products of Potassium chloride in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Upsher-Smith Laboratories, LLC.
What Potassium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Klor-Con is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. …
— FDA label: Klor-Con, Upsher-Smith Laboratories, LLC, effective July 14, 2025. Read the full label on DailyMed →
The FDA has 194 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 194 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet, film coated, extended release · Solution · Capsule, extended release · Powder, for solution · Injection, solution, concentrate · Injection · For solution · Tablet · Injection, solution |
|---|---|
| Route | Oral · Intravenous · Parenteral |
| Prescription products | 286 in the FDA NDC Directory |
| Brand names | Klor-Con, Klor-Con M, Pokonza, Pokonza Potassium Chloride |
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 |
|---|---|---|
| potassium chloride 0.75 g/0.79 g powder, for solution | Brand: Pokonza | $28.26 per unit |
| potassium chloride 1.5 g powder, for solution | Brand: Klor-Con | $0.6231 per unit |
| potassium chloride 1.5 g/1.58 g for solution | Generic | $0.6719 per unit |
| potassium chloride 1.5 g/1.58 g powder, for solution | Generic | $0.6719 per unit |
| potassium chloride 1.5 g/1.77 g powder, for solution | Generic | $0.6719 per unit |
| potassium chloride 1.5 g/15 mL solution | Generic | $0.0410 per mL |
| potassium chloride 10 meq tablet, film coated, extended release | Generic | $0.0838 per tablet |
| potassium chloride 1125 mg tablet, extended release | Brand: Klor-Con M | $0.4824 per tablet |
| potassium chloride 1500 mg tablet | Generic | $0.1437 per tablet |
| potassium chloride 1500 mg tablet, extended release | Generic | $0.1437–$0.1935 per tablet 10 packages, lowest to highest |
| potassium chloride 1500 mg tablet, extended release | Brand: Klor-Con M | $0.1422 per tablet |
| potassium chloride 1500 mg tablet, film coated, extended release | Generic | $0.1935 per tablet |
| potassium chloride 20 meq tablet, extended release | Generic | $0.1437 per tablet |
| potassium chloride 20 meq/15 mL solution | Generic | $0.0410 per mL |
| potassium chloride 3 g/15 mL solution | Generic | $0.0621 per mL |
| potassium chloride 40 meq/15 mL solution | Generic | $0.0621 per mL |
| potassium chloride 600 mg capsule, extended release | Generic | $0.1045 per capsule |
| potassium chloride 600 mg tablet, extended release | Generic | $0.1138 per tablet |
| potassium chloride 600 mg tablet, film coated, extended release | Generic | $0.1138 per tablet |
| potassium chloride 600 mg tablet, film coated, extended release | Brand: Klor-Con | $0.1181 per tablet |
| potassium chloride 750 mg capsule, extended release | Generic | $0.1357 per capsule |
| potassium chloride 750 mg tablet | Generic | $0.1329 per tablet |
| potassium chloride 750 mg tablet, extended release | Generic | $0.0838–$0.1329 per tablet 25 packages, lowest to highest |
| potassium chloride 750 mg tablet, extended release | Brand: Klor-Con M | $0.1327 per tablet |
| potassium chloride 750 mg tablet, film coated, extended release | Generic | $0.0838 per tablet |
| potassium chloride 750 mg tablet, film coated, extended release | Brand: Klor-Con | $0.1198 per tablet |
| potassium chloride 8 meq tablet, film coated, extended release | Generic | $0.1138 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 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.
- A-S Medication Solutions22 products
- Bryant Ranch Prepack20 products
- Upsher-Smith Laboratories, LLC14 products
- Aphena Pharma Solutions - Tennessee, LLC9 products
- Granules Pharmaceuticals Inc.9 products
- Aurobindo Pharma Limited7 products
- American Health Packaging7 products
- Major Pharmaceuticals7 products
- Fresenius Kabi USA, LLC7 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Advagen Pharma Ltd6 products
- Lupin Pharmaceuticals, Inc.6 products
- Remedyrepack Inc.6 products
- Northwind Health Company, LLC6 products
- Proficient Rx LP5 products
- Camber Pharmaceuticals, Inc.5 products
- BluePoint Laboratories5 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- Solco Healthcare LLC5 products
- Direct_Rx4 products
- Granules India Ltd4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Slate Run Pharmaceuticals, LLC4 products
- AvKARE4 products
- Macleods Pharmaceuticals Limited4 products
- Sun Pharmaceutical Industries, Inc.4 products
- PAI Holdings, LLC dba PAI Pharma4 products
- Hospira, Inc.3 products
- XLCare Pharmaceuticals, Inc.3 products
- Advagen Pharma Limited3 products
- ICU Medical Inc.3 products
- Carwin Pharmaceutical Associates, LLC3 products
- Guardian Drug Company3 products
- Baxter Healthcare Corporation3 products
- Atlantic Biologicals Corp.3 products
- BPI Labs LLC3 products
- Strides Pharma Science Limited3 products
- NorthStar Rx LLC3 products
- Ajenat Pharmaceuticals LLC3 products
- Cardinal Health 107, LLC3 products
- Kesin Pharma Corporation3 products
- Marlex Pharmaceuticals, Inc.3 products
- Nexus Pharamaceuticals Inc.3 products
- Epic Pharma, LLC3 products
- Redpharm Drug3 products
- AvPAK3 products
- Rising Pharma Holdings, Inc.2 products
- Amneal Pharmaceuticals NY LLC2 products
- Mylan Pharmaceuticals Inc.2 products
- Upsher-SmithLaboratories, LLC2 products
- Dr.Reddys Laboratories Inc2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Quagen Pharmaceuticals LLC2 products
- Zydus Lifesciences Limited2 products
- Actavis Pharma, Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Tris Pharma Inc2 products
- Adare Pharmaceuticals Inc2 products
- Saptalis Pharmaceuticals, LLC.2 products
- Henry Schein, Inc.2 products
- Amneal Pharmaceuticals LLC1 product
- Genus Lifesciences1 product
- ANI Pharmaceuticals, Inc.1 product
- Novel Laboratories, Inc.1 product
- IPG Pharmaceuticals, Inc.1 product
- Genus Lifesciences Inc.1 product
- Endo USA, Inc.1 product
- St. Mary's Medical Park Pharmacy1 product
- Amneal Pharmaceuticals of New York LLC1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Coupler LLC1 product
- Somerset Therapeutics, LLC1 product
- B. Braun Medical 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 |
|---|---|---|---|
| NDA019123 KLOR-CON | Upsher Smith Labs | April 17, 1986 | 24, latest April 30, 2018 2018: Labeling · 2013: Manufacturing (CMC) · 2007: Manufacturing (CMC) |
| NDA019904 POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | Baxter Hlthcare | December 26, 1989 | 16, latest June 13, 2024 2024: Labeling · 2022: Labeling · 2019: Labeling |
| NDA020161 POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | Otsuka Icu Medcl | November 30, 1992 | 10, latest November 1, 2002 2002: Manufacturing (CMC) · 2001: Manufacturing (CMC) · 1999: Labeling |
| NDA206814 POKONZA, POTASSIUM CHLORIDE | Genus Lifesciences | December 22, 2014 | 5, latest June 12, 2026 2026: Manufacturing (CMC) · 2020: Labeling · 2019: Manufacturing (CMC) |
| NDA208019 POKONZA, POTASSIUM CHLORIDE | Genus | August 19, 2015 | 3, latest November 12, 2025 2025: Manufacturing (CMC) · 2020: Labeling · 2019: Labeling |
Generic approvals (61)
- ANDA080205Hospira · March 16, 1972
- ANDA085870B Braun · March 21, 1978
- ANDA088901Fresenius Kabi USA · January 25, 1985
- ANDA088908Fresenius Kabi USA · January 25, 1985
- ANDA074726Upsher Smith Labs · November 20, 1998
- ANDA075604Actavis Labs Fl Inc · April 10, 2002
- ANDA076368Adare Pharms Inc · August 18, 2004
- ANDA077419Actavis Labs Fl Inc · June 2, 2008
- ANDA202128Amneal Pharms · February 22, 2013
- ANDA204662Pharmobedient · August 21, 2014
- ANDA203002Lupin · December 18, 2015
- ANDA202868Glenmark Pharms Ltd · January 19, 2016
- ANDA206347Novel Labs Inc · January 21, 2016
- ANDA203562Glenmark Pharms Ltd · July 26, 2016
- ANDA208864Adare Pharms Inc · March 17, 2017
- ANDA209662Upsher Smith Labs · October 23, 2017
- ANDA209688Twi Pharms · January 12, 2018
- ANDA209314Yichang Humanwell · June 22, 2018
- ANDA210041Amneal · July 19, 2018
- ANDA209786Novel Labs Inc · August 29, 2018
- ANDA210733Strides Pharma · August 31, 2018
- ANDA210241Novel Labs Inc · November 21, 2018
- ANDA210200Epic Pharma LLC · November 23, 2018
- ANDA210921Aurobindo Pharma · December 19, 2018
- ANDA208445Zydus Pharms · March 11, 2019
- ANDA210766Pharm Assoc · March 29, 2019
- ANDA209922Prinston Inc · April 30, 2019
- ANDA212183Ajenat Pharms · May 6, 2019
- ANDA210902Amneal · May 23, 2019
- ANDA209026Prinston Inc · June 11, 2019
- ANDA212561Yichang Humanwell · September 30, 2019
- ANDA211797Granules · March 4, 2020
- ANDA212861Amneal · May 8, 2020
- ANDA211087Fresenius Kabi USA · September 9, 2020
- ANDA210395Zydus Pharms · September 17, 2020
- ANDA214452Granules · October 21, 2020
- ANDA214422Ascent Pharms Inc · December 29, 2020
- ANDA213392Granules · January 29, 2021
- ANDA214686Granules · February 16, 2021
- ANDA211667Strides Pharma · March 11, 2021
Showing the 40 earliest of 61.
Shortage status
To be discontinued · updated November 21, 2025 · first posted November 21, 2025
| Product | Potassium Chloride, Tablet, Extended Release, 20 meq (NDC 62037-720-10) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
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.
-
October 29, 2025 · Class I · Ongoing · D-0180-2026
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14 — Otsuka ICU Medical LLC
-
October 29, 2025 · Class I · Ongoing · D-0181-2026
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26 — Otsuka ICU Medical LLC
-
February 13, 2025 · Class I · Ongoing · D-0268-2025
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 — ICU Medical, Inc.
-
February 13, 2025 · Class I · Ongoing · D-0267-2025
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; — ICU Medical, Inc.
-
January 30, 2025 · Class II · Ongoing · D-0221-2025
Failed Dissolution Specifications.
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ — The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
-
June 25, 2024 · Class I · Ongoing · D-0619-2024
Failed Dissolution Specifications
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, — Amerisource Health Services LLC
-
March 6, 2024 · Class II · Terminated · D-0370-2024
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20 — B. Braun Medical Inc
-
September 27, 2021 · Class II · Terminated · D-0006-2022
Failed Dissolution Specifications
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, ND — Strides Pharma Inc.
-
August 24, 2020 · Class II · Terminated · D-0001-2021
Failed Dissolution Specifications
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brun — Strides Inc.
-
February 17, 2020 · Class III · Terminated · D-1029-2020
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816 — Strides Pharma Science Limited
-
November 10, 2014 · Class II · Terminated · D-0256-2015
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826. — Baxter Healthcare Corp.
-
September 8, 2014 · Class II · Terminated · D-1606-2014
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48. — Baxter Healthcare Corp
-
July 11, 2014 · Class I · Terminated · D-1593-2014
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822. — Baxter Healthcare Corp.
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) | 198116, 204520, 312504, 312507, 312515, 312529, 314182, 315183, 403888, 628953 … (+10) |
|---|---|
| SPL set ID of the quoted label | 1ff53330-065c-4213-9c0c-ac498621d09d |
| FDA labels (SPL) | 194 |
| FDA applications | NDA019123, NDA019904, NDA020161, NDA206814, NDA208019, 61 ANDA |
| Active ingredients (FDA) | POTASSIUM CHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Klor-Con, Upsher-Smith Laboratories, LLC, effective July 14, 2025; 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 →