CLASS I ONGOING Drug recall · Reported 26 Nov 2025 · FDA Enforcement Report
Potassium Chloride Inj., 20 mEq total in Flexible Container recalled
Otsuka ICU Medical is recalling Potassium Chloride Inj., 20 mEq total in Flexible Container, Highly concentrated 400 mEq/L, distributed nationwide in the US. The recall was initiated on 29 Oct 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0180-2026
- FDA event ID
- 97888
- Recalling firm
- Otsuka ICU Medical, Austin, TX
- Brand
- Potassium Chloride
- Manufacturer
- ICU Medical Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 29 Oct 2025
- FDA classified
- 24 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Oct 2025 | Recall initiated by company | |
| 24 Nov 2025 | Classified by FDA | +26 days |
| 26 Nov 2025 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot # 1030613, Exp Date: 09/30/2026
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97888This product is part of a recall event; the main page for the event is Potassium Chloride Inj., 10 mEq total in Flexible Container recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
More recalls from Otsuka ICU Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | ANNOUNCED | ICU Medical LLC 0.9% Sodium Chloride Injection recalledICU Medical LLC | Otsuka ICU Medical | Packaging Defects | |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS II | 0.9% Sodium Chloride Injection recalled by Otsuka ICU MedicalSodium Chloride | Otsuka ICU Medical | Sterility | Nationwide |
Other Potassium Chloride recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |