Potassium Chloride recalls
The FDA has published 23 recalls involving Potassium Chloride since 2013. The latest was reported on 26 Nov 2025. Most were for potency & assay. Glenmark Pharmaceuticals Inc., USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 23 since 2013
Last 12 months 2 reported
Class I 8 35% of total
Ongoing 10 latest 26 Nov 2025
Recalls per month, last 24 months click a bar for that month Severity split
8 35%13 57%2 9%
Why potassium chloride is recalled
Ongoing potassium chloride recalls 10 active
All potassium chloride recalls, newest first 23 total Reported Class Recall Company Reason Where 26 Nov 2025 Drug CLASS I Potassium Chloride Inj., 20 mEq total in Flexible Container recalled Potassium Chloride Otsuka ICU Medical Other Nationwide 26 Nov 2025 Drug CLASS I Potassium Chloride Inj., 10 mEq total in Flexible Container recalled Potassium Chloride Otsuka ICU Medical Other Nationwide 19 Mar 2025 Drug CLASS I Potassium Chloride Inj., 20 mEq total in flexible container recalled Potassium Chloride ICU Medical Labeling Errors Nationwide 19 Mar 2025 Drug CLASS I Potassium Chloride Inj., 10 mEq total recalled by ICU Medical Potassium Chloride ICU Medical Other Nationwide 12 Feb 2025 Drug CLASS II Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalled Potassium Chloride The Harvard Drug Group Potency & Assay Nationwide 7 Aug 2024 Drug CLASS I Potassium Chloride Extended-Release Capsules recalled Potassium Chloride Amerisource Health Services Potency & Assay Nationwide 24 Jul 2024 Drug CLASS II Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalled Glenmark Pharmaceuticals Inc., USA Manufacturing (CGMP) Deviations Nationwide 24 Jul 2024 Drug CLASS I Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalled Glenmark Pharmaceuticals Inc., USA Potency & Assay Nationwide 24 Jul 2024 Drug CLASS I Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalled Glenmark Pharmaceuticals Inc., USA Potency & Assay Nationwide 24 Jul 2024 Drug CLASS II Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalled Glenmark Pharmaceuticals Inc., USA Manufacturing (CGMP) Deviations Nationwide 20 Mar 2024 Drug CLASS II Potassium Chloride for Injection Concentrate USP, 500 mEq recalled Potassium Chloride B. Braun Medical Sterility Nationwide 20 Oct 2021 Drug CLASS II Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg) recalled Potassium Chloride Strides Pharma Potency & Assay Nationwide 7 Oct 2020 Drug CLASS II Pharma Inc.Potassium Chloride Extended-Release Tablets recalled Potassium Chloride Strides Potency & Assay Nationwide 25 Mar 2020 Drug CLASS III Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg) recalled Potassium Chloride Strides Pharma Science Other Nationwide 15 Feb 2017 Drug CLASS II Potassium Chloride Oral Solution, USP, 10%, 20 mEq recalled VistaPharm Packaging Defects 36 states 27 Apr 2016 Drug CLASS II Potassium Chloride Injection 20 mEq, 400 mEq/L recalled by Hospira Hospira Packaging Defects Nationwide 25 Nov 2015 Drug CLASS II Potassium Chloride Injection (20mEq/, 2mEq/ML vial recalled Downing Labs Sterility Nationwide 22 Apr 2015 Drug CLASS III Potassium Chloride, microencapsulated extended-release recalled Cardinal Health Packaging Defects OK 3 Dec 2014 Drug CLASS II Potassium Chloride in 5% Dextrose recalled by Hospira Hospira Sterility Nationwide 3 Dec 2014 Drug CLASS II Potassium Chloride Injection recalled by Baxter Healthcare Potassium Chloride Baxter Healthcare Other Nationwide 1 Oct 2014 Drug CLASS II Potassium Chloride Injection, 10 mEq recalled by Baxter Healthcare Potassium Chloride Baxter Healthcare Packaging Defects Nationwide 24 Sep 2014 Drug CLASS I Potassium Chloride Injection recalled by Baxter Healthcare Potassium Chloride Baxter Healthcare Particulate Matter Nationwide 18 Sep 2013 Drug CLASS II Potassium Chloride 2 Meq/ML Injectable, all presentations recalled Beacon Hill Medical Pharmacy, P.C Sterility Nationwide
Should you stop taking Potassium Chloride?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.