FDA Recall: ICU Medical
Source: FDA
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FDA Recall: ICU Medical

ICU Medical • November 03, 2025

FDA Recall: ICU Medical Potassium Chloride Injection Mislabeling

Urgent consumer alert: ICU Medical’s 20 mEq Potassium Chloride Injection is being voluntarily recalled nationwide because the outer overwrap is incorrectly labeled as 10 mEq. Administering the higher-strength bag could cause life-threatening hyperkalemia. Check your inventory immediately.

ICU Medical Potassium Chloride Recall Summary

  • Recall announced: 31 Oct 2025 (posted by FDA 03 Nov 2025)
  • Product category: Prescription drug – Potassium Chloride Injection
  • Reason for recall: Overwrap mislabeled as lower-strength 10 mEq; actual bag contains 20 mEq
  • Manufacturer: Otsuka ICU Medical LLC, Austin, TX
  • Health hazard: Potential potassium overdose leading to hyperkalemia, arrhythmias, or cardiac arrest

Sources

Affected Lot Identification

  • NDC: 0990-7077-14
  • List number: 070770452
  • Lot number: 1030613
  • Expiration date: 30 Sep 2026
  • Package: 50 mL flexible container, 24 bags per case
  • Distribution: 23 May 2025 – 26 Aug 2025 (U.S.)

The 20 mEq bag is sealed in an overwrap that incorrectly states “10 mEq Potassium Chloride Injection” (NDC 0990-7074-26). The correct 20 mEq strength is printed on the inner bag but is hidden until the overwrap is removed.

Patient Safety Risks

An unintended 20 mEq infusion doubles the intended potassium load and can rapidly trigger severe hyperkalemia. Warning signs include:

  • Muscle weakness or ascending paralysis
  • Hypotension, vertigo, mental confusion
  • Cardiac dysrhythmias or arrest

Premature infants, patients on parenteral nutrition, individuals with renal impairment, existing arrhythmias, or those taking potassium-sparing diuretics are at greatest risk.

Action Steps for Healthcare Providers & Consumers

  1. Quarantine inventory: Stop using or dispensing the affected lot immediately.
  2. Verify labels: Cross-check NDC and lot on both the overwrap and the inner bag. If they show lot 1030613, the unit is recalled.
  3. Arrange returns: Contact Sedgwick at 1-888-566-2363 (Mon–Fri, 8 a.m.–5 p.m. ET) for a prepaid return kit.
  4. Report adverse events: Submit to FDA MedWatch at www.fda.gov/medwatch/report.htm or by fax/mail using Form 3500.

ICU Medical Contact Information

Recall Photos: Mislabelled vs. Correct Bags

Incorrect 10 mEq overwrap for 20 mEq Potassium Chloride
Source: FDA
Correct overwrap showing 20 mEq Potassium Chloride
Source: FDA
Side-by-side comparison of mislabeled overwrap and actual product bag
Source: FDA

Frequently Asked Questions

Why is the ICU Medical Potassium Chloride Injection being recalled?
A manufacturing mix-up placed a 10 mEq overwrap on 20 mEq bags, risking accidental double dosing and dangerous hyperkalemia.
Which NDC and lot numbers of ICU Medical Potassium Chloride are affected?
Only lot 1030613 with NDC 0990-7077-14 (20 mEq, 50 mL) is included in the recall.
What health risks exist if the recalled ICU Medical Potassium Chloride is used?
An unintended 20 mEq infusion can lead to severe hyperkalemia, causing muscle weakness, cardiac arrhythmias, or cardiac arrest.
How can I confirm my ICU Medical Potassium Chloride stock is recalled?
Check the overwrap and inner bag for NDC 0990-7077-14 and lot 1030613. A 10 mEq overwrap on a 20 mEq bag is definitive.
What should I do with recalled ICU Medical Potassium Chloride inventory?
Cease use, quarantine the product, and contact Sedgwick at 1-888-566-2363 for prepaid return instructions.
Can I still use the ICU Medical Potassium Chloride bag if the inner label shows 20 mEq?
No. ICU Medical requires all units from the affected lot to be returned to eliminate dosing errors.

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