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., USA. 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

0Nov '24 0 0 1Feb 2 0 0May 0 0 0Aug 0 0 2Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

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

Why potassium chloride is recalled

Companies

Product types

Injectable & IV Drugs17100%

By year

2025529%
2024635%
202116%
2020212%
2014318%

Ongoing potassium chloride recalls

10 active

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride	ICU Medical	Labeling Errors	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride	ICU Medical	Other	Nationwide
12 Feb 2025Drug	CLASS II	Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride	The Harvard Drug Group	Potency & Assay	Nationwide
7 Aug 2024Drug	CLASS I	Potassium Chloride Extended-Release Capsules recalledPotassium Chloride	Amerisource Health Services	Potency & Assay	Nationwide

All potassium chloride recalls, newest first

17 total

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride	ICU Medical	Labeling Errors	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride	ICU Medical	Other	Nationwide
12 Feb 2025Drug	CLASS II	Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride	The Harvard Drug Group	Potency & Assay	Nationwide
7 Aug 2024Drug	CLASS I	Potassium Chloride Extended-Release Capsules recalledPotassium Chloride	Amerisource Health Services	Potency & Assay	Nationwide
24 Jul 2024Drug	CLASS II	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalledPotassium Chloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jul 2024Drug	CLASS I	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalledPotassium Chloride	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
24 Jul 2024Drug	CLASS I	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalledPotassium Chloride	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
24 Jul 2024Drug	CLASS II	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq recalledPotassium Chloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
20 Mar 2024Drug	CLASS II	Potassium Chloride for Injection Concentrate USP, 500 mEq recalledPotassium Chloride	B. Braun Medical	Sterility	Nationwide
20 Oct 2021Drug	CLASS II	Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg) recalledPotassium Chloride	Strides Pharma	Potency & Assay	Nationwide
7 Oct 2020Drug	CLASS II	Pharma Inc.Potassium Chloride Extended-Release Tablets recalledPotassium Chloride	Strides	Potency & Assay	Nationwide
25 Mar 2020Drug	CLASS III	Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg) recalledPotassium Chloride	Strides Pharma Science	Other	Nationwide
3 Dec 2014Drug	CLASS II	Potassium Chloride Injection recalled by Baxter HealthcarePotassium Chloride	Baxter Healthcare	Other	Nationwide
1 Oct 2014Drug	CLASS II	Potassium Chloride Injection, 10 mEq recalled by Baxter HealthcarePotassium Chloride	Baxter Healthcare	Packaging Defects	Nationwide
24 Sep 2014Drug	CLASS I	Potassium Chloride Injection recalled by Baxter HealthcarePotassium Chloride	Baxter Healthcare	Particulate Matter	Nationwide

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.