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 recalls23since 2013
Last 12 months2reported
Class I835% of total
Ongoing10latest 26 Nov 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 8 35%Class II 13 57%Class III 2 9%
Why potassium chloride is recalled
Companies
By year
Ongoing potassium chloride recalls
10 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride | ICU Medical | Labeling Errors | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride | ICU Medical | Other | Nationwide |
| Drug | CLASS II | Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS I | Potassium Chloride Extended-Release Capsules recalledPotassium Chloride | Amerisource Health Services | Potency & Assay | Nationwide |
All potassium chloride recalls, newest first
23 totalShould 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.