Potassium Chloride recalls

Potassium Chloride products have been recalled 17 times, most recently on 26 Nov 2025. The recalling company is usually Glenmark Pharmaceuticals Inc., U. The most common reason is potency & assay.

Total recalls17since 2014
Last 12 months2reported
Class I847% of total
Ongoing10latest 26 Nov 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 8 47%Class II 8 47%Class III 1 6%

Product types

By year

Ongoing potassium chloride recalls

10 active

All potassium chloride recalls, newest first

17 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IPotassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium ChlorideOtsuka ICU MedicalOtherNationwide
DrugCLASS IPotassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium ChlorideOtsuka ICU MedicalOtherNationwide
DrugCLASS IPotassium Chloride Inj., 20 mEq total in flexible container recalledPotassium ChlorideICU MedicalLabeling ErrorsNationwide
DrugCLASS IPotassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium ChlorideICU MedicalOtherNationwide
DrugCLASS IIPotassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium ChlorideThe Harvard Drug GroupPotency & AssayNationwide
DrugCLASS IPotassium Chloride Extended-Release Capsules recalledPotassium ChlorideAmerisource Health ServicesPotency & AssayNationwide
DrugCLASS IIPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K recalledPotassium ChlorideGlenmark Pharmaceuticals Inc., UManufacturing (CGMP) DeviationsNationwide
DrugCLASS IPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K recalledPotassium ChlorideGlenmark Pharmaceuticals Inc., UPotency & AssayNationwide
DrugCLASS IPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K recalledPotassium ChlorideGlenmark Pharmaceuticals Inc., UPotency & AssayNationwide
DrugCLASS IIPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K recalledPotassium ChlorideGlenmark Pharmaceuticals Inc., UManufacturing (CGMP) DeviationsNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.