Otsuka ICU Medical LLC has announced a voluntary nationwide recall of a specific lot of potassium chloride injection due to a critical labeling error on the overwrap. Clinical, quality, and regulatory teams across the healthcare sector should take immediate note of this recall for patient safety and regulatory compliance.
Recall Details
On October 31, 2025, Otsuka ICU Medical LLC issued an urgent recall of lot 1030613 of Potassium Chloride Injection 20 mEq. The overwrap on this lot was mislabelled as Potassium Chloride Injection 10 mEq, presenting a significant risk of overdose. The affected lot carries the incorrect NDC code of 0990-7074-26 on the overwrap, while the correct dosage and code (0990-7077-14) are printed on the product bag itself, which remains obscured under the mislabeled overwrap.
Manufacturing Origin and Distribution Timeline
This lot was manufactured on April 15, 2025, and distributed across the United States between May 23, 2025, and August 26, 2025. The manufacturer has cited a production issue as the root cause of the labeling error and confirmed that no adverse events have been reported so far.
Clinical Risks of the Mislabeled Product
If the mislabeled overwrap leads healthcare professionals to administer the product based on its incorrect information, there is a risk of administering double the intended dose of potassium chloride. This could result in hyperkalemia, a potentially life-threatening condition. Symptoms of severe hyperkalemia include muscle weakness, paralysis, cardiac arrhythmias, mental confusion, and risk of death via cardiac arrest. Vulnerable patient populations include premature infants, individuals on chronic parenteral nutrition, those with renal insufficiency, and patients using potassium-sparing diuretics. Continuous cardiac monitoring and frequent serum potassium testing are highly recommended when administering potassium chloride injections.
Who Needs to Act?
Healthcare providers, distributors, and clinical teams must cease usage of the recalled lot immediately. If any affected products remain in circulation, they must be returned to the point of purchase. Otsuka ICU Medical LLC has provided multiple contact avenues for inquiries and product return labels, including Sedgwick at 1-888-566-2363 (M-F, 8am–5pm ET) and various email contacts such as globalcomplaints@icumed.com and customerservice@icumed.com.
Reporting Adverse Events
Any adverse reactions observed with this product should be reported to the FDA’s MedWatch program. Reports can be submitted online or through regular mail or fax. Comprehensive instructions for reporting are accessible at www.fda.gov/medwatch/report.htm.
Next Steps for Compliance
Otsuka ICU Medical LLC has informed the FDA about the recall. Healthcare institutions are advised to communicate the issue to all relevant teams and ensure compliance with the recall instructions to prevent harm and regulatory penalties.
Disclaimer
This blog post is created for informational purposes targeted at healthcare professionals and regulatory teams. It is not legal advice and should not replace official recall notices or regulatory directives.
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due