Potassium Chloride is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
Class I recall (most serious) — November 26, 2025: 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 Only the lots listed are affected. Check the lots
- Type
- Prescription only (Rx)
- Brand names
- Klor-con, Pokonza, Klor-con M
- Taken
- Oral
- Label
- Carwin Pharmaceutical Associates, LLC, revised January 22, 2026 · full label on DailyMed
- Generic
- FDA-approved (33 companies) · details
What it is used for
POKONZA ® (Potassium Chloride Oral Solution, USP) 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 are insufficient. POKONZA ® (Potassium Chloride Oral Solution, USP) 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 are insufficient. ( 1 )
Forms and strengths
Oral Solution 5%: 10 mEq/15 mL Oral Solution: 5%; 10 mEq/15mL potassium per mL ( 3 )
Who should not take it (contraindications)
POKONZA ® is contraindicated in patients on potassium sparing diuretics. Concomitant use with potassium sparing diuretics. ( 4 )
Warnings and precautions
Gastrointestinal Irritation : Dilute before use, take with meals ( 5.1 )
5.1 Gastrointestinal Irritation May cause gastrointestinal irritation if administered undiluted. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1) ] .
Side effects (adverse reactions)
The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Carwin Pharmaceutical Associates at 1-844-700-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug interactions
Potassium sparing diuretics: Avoid concomitant use ( 7.1 ) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.2 ) Nonsteroidal Anti-Inflammatory drugs: Monitor for hyperkalemia ( 7.3 )
7.1 Potassium-Sparing Diuretics Use with potassium-sparing diuretics can produce severe hyperkalemia. Avoid concomitant use.
7.2 Renin-Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy.
7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDs may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.
Pregnancy, breastfeeding, children and older adults
Cirrhosis: Initiate therapy at the low end of the dosing range ( 8.6 ) Renal Impairment: Initiate therapy at the low end of the dosing range ( 8.7 )
8.1 Pregnancy There are no human data related to use of POKONZA ® during pregnancy, and animal studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2 Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as POKONZA ® becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.
8.4 Pediatric Use The safety and effectiveness of POKONZA ® have been demonstrated in children with diarrhea and malnutrition from birth to 16 years.
8.5 Geriatric Use Clinical studies of POKONZA ® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
8.6 Cirrhotics Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently. [see Clinical Pharmacology (12.3) ] .
8.7 Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on ACE inhibitors, ARBs, or nonsteroidal anti-inflammatory drugs should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia. The serum potassium level should be monitored frequently. Renal function should be assessed periodically.
How it works
The potassium ion (K+) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 mEq to 160 mEq per liter. The normal adult plasma concentration is 3.5 mEq to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 mEq to 100 mEq per day.
Is there a generic Potassium Chloride?
Yes. The FDA has approved generic Potassium Chloride from 33 companies whose approvals are active. The earliest of these was approved in 1972.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Actavis Labs Fl Inc, Adaptis, Adare Pharms Inc, Ajenat Pharms, Amneal, Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma, B Braun, Epic Pharma Llc, Fresenius Kabi Usa, Granules, Guangzhou Novaken, Hospira, Macleods Pharms, Nexus, Novel Labs Inc, Novitium Pharma, Padagis Us, Pharm Assoc, Pharmobedient, Prinston Inc, Quagen, Rising, Rubicon Research, Sciegen Pharms, Strides Pharma, Taro, Twi Pharms, Upsher Smith Labs, Wes Pharma Inc, Yichang Humanwell, Zydus Pharms
Brand-name versions
- Kaon Cl Savage Labs Discontinued
- Ten-k Novartis Discontinued
- Slow-k Novartis, approved 1975 Discontinued
- Klotrix Apothecon, approved 1980 Discontinued
- K-tab Abbvie, approved 1980 Discontinued
- Micro-k Nesher Pharms, approved 1980 Discontinued
- Klor-con Upsher Smith Labs, approved 1986
- Micro-k Ls Kv Pharm, approved 1988 Discontinued
- Potassium Chloride 20meq In Plastic Container Baxter Hlthcare, approved 1989
- Pokonza Genus Lifesciences, approved 2014
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Potassium in the news
We have not covered this medicine yet. Latest news
Products being discontinued
| Product | Availability | Expected supply / notes |
|---|---|---|
| Cardioplegic Solution, Injection, Solution, 17.6 mg/100 mL; 325.3 mg/100 mL; 119.3 mg/100 mL; 643 mg/100 mL (NDC 65219-258-10) Fresenius Kabi USA, LLC |
Discontinuation of the manufacture of the drug Being discontinued · August 31, 2026 |
|
| Potassium Chloride, Tablet, Extended Release, 20 meq (NDC 62037-720-10) Teva Pharmaceuticals USA, Inc. |
Discontinuation of the manufacture of the drug Being discontinued · November 21, 2025 |
|
| Potassium Chloride, Tablet, Extended Release, 20 meq (NDC 62037-720-05) Teva Pharmaceuticals USA, Inc. |
Discontinuation of the manufacture of the drug Being discontinued · November 21, 2025 |
|
| Potassium Chloride, Tablet, Extended Release, 20 meq (NDC 62037-720-01) Teva Pharmaceuticals USA, Inc. |
Discontinuation of the manufacture of the drug Being discontinued · November 21, 2025 |
|
| Potassium Chloride, Tablet, Extended Release, 10 meq (NDC 62037-710-01) Teva Pharmaceuticals USA, Inc. |
Discontinuation of the manufacture of the drug Being discontinued · November 21, 2025 |
Recalls
-
Class I Ongoing
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
Reason: 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
Lots, distribution and details
- Lots / codes
- Lot # 1030613, Exp Date: 09/30/2026
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- October 29, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0181-2026
-
Class I Ongoing
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
Reason: 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
Lots, distribution and details
- Lots / codes
- Lot # 1030613, Exp Date: 09/30/2026
- Distribution
- US Nationwide.
- Quantity
- 21,696 50mL flexible containers
- Recall started
- October 29, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0180-2026
-
Class I Ongoing
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
Reason: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Lots, distribution and details
- Lots / codes
- Lot 1023172, Exp Date: 31 January 2026
- Distribution
- Nationwide in the USA
- Quantity
- unknown
- Recall started
- February 13, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0268-2025
-
Class I Ongoing
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;…
Reason: 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.
Lots, distribution and details
- Product
- 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; Case (01)30309907075267
- Lots / codes
- Lot 1023172, Exp Date: 31 January 2026
- Distribution
- Nationwide in the USA
- Quantity
- 67,488 flexible containers
- Recall started
- February 13, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0267-2025
-
Class II Ongoing
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…
Reason: Failed Dissolution Specifications.
Lots, distribution and details
- Product
- 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 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61
- Lots / codes
- Lot# T05224; Exp. 02/2026
- Distribution
- Nationwide in the USA
- Quantity
- 6997 cartons
- Recall started
- January 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0221-2025
-
Class I Ongoing
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,…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- 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, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
- Lots / codes
- [100 count bottles]: Lot 17221738, Exp 07/31/2024; Lot 17222494, Exp 10/31/2024; Lot 17230533, Exp 01/31/2025; Lot 17232208, Exp 09/30/2025; [500 count bottles]: Lot 17221823, Lot 17221830, Exp 07/31/2024; Lot 17221831, Exp 08/31/2024; Lot 17230248, Lot 17230253, Lot 17230271, Exp 12/31/2024; Lot 17230796, Lot 17230820, Exp 02/28/2025; Lot 17230825, Lot 17230833, Lot 17230840, Exp 03/31/2025; Lot 17231537, Lot 17231540, Lot 17231719, Lot 17231737, Exp 06/30/2025; Lot 17232111, Lot 17232164, Exp 09/30/2025
- Distribution
- US Nationwide.
- Quantity
- 61,231 bottles
- Recall started
- June 25, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0619-2024
-
Class II Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
- Lots / codes
- Lot #: 17230186, 17230192, 17230213, 17230278, 17230399, Exp Dec-31-24; 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, Exp Jan-31-25; 17230574, 17230585, 17230608, 17230629, Exp Feb-28-25; 17230883, 17230921, Exp Mar-31-25; 17231087, 17231339, Exp Apr-30-25; 17231360, Exp May-31-25; 17231711, 17231745, Exp Jun-30-25; 17231819, 17231820, 17231936, 17231957, Exp Jul-31-25; 17231998, 17232012, Aug-31-25; 17232110, Exp Sep-30-25; 17232114, Exp Aug-31-25; 17232119, 17232343, Exp Sep-30-25.
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0607-2024
-
Class II Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
- Lots / codes
- Lot #: 17230074, 17230221, Exp Dec-31-24; 17230468, 17230479, 17230553, 17230543, 17230561, Exp Jan-31-25; 17230619, 17230624, Exp Feb-28-25; 17230879, 17230890, 17230918, 17230984, 17230996, 17231002, 17231081, Exp Mar-31-25; 17231102, 17231135, 17231329, Exp Apr-30-25; 17231369, 17231513, Exp May-31-24; 17231516, 17231713, Exp Jun-30-25; 17231909, 17231903, Exp Jul-31-25; 17231943, Exp Aug-31-25; 17232166, 17232179, Exp Sep-30-25.
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0606-2024
-
Class I Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
- Lots / codes
- Lot #: 17221197, 17221386, 17221385, Exp May-31-24; 17221489, 17221504, 17221530, Exp Jun-30-24; 17221561, 17221579, 17221568, 17221702, 17221704, Exp Jul-31-24; 17221898, 17221993, 17222029, Exp Aug-31-24; 17222300, 17222304, 17222278, 17222609, 17222395, Exp Oct-31-24; 17222589, 17222605, 17222613, Exp Nov-30-24;
- Distribution
- Nationwide
- Quantity
- 36,630 bottles
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0605-2024
-
Class I Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
- Lots / codes
- Lot#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17221566, 17221719, 17221731, Exp Jul-31-24; 17221891, 17221892, 17221900, 17221992, 17222022, Exp Aug-31-24; 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, Exp Sep-30-24; 17222265, 17222269, Exp Oct-31-24; 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067, Exp Nov-30-24;
- Distribution
- Nationwide
- Quantity
- 285,840 bottles
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0604-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Potassium Chloride
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 2d938cbf-27aa-4f9c-a582-5564d3b72465.