Clinical professionals, regulatory teams, and healthcare providers should note the recent voluntary nationwide recall of a potassium chloride injection product. On October 31, 2025, Otsuka ICU Medical LLC initiated this action after discovering a mislabeling issue affecting the overwrap of its Potassium Chloride Injection 20 mEq product, which is improperly labeled as 10 mEq.
Key points:
- The recall impacts users at the clinical level, posing potential overdose risks.
- Affected lot: 1030613, manufactured April 15, 2025, distributed May 23, 2025–August 26, 2025.
- Overdose hazards include symptoms of hyperkalemia with potentially fatal outcomes.
In this article:
- What is the issue with the product?
- What products are being recalled?
- How can affected products be returned?
- FAQ
- Conclusion
- Disclaimer
- FDA Announcement
What is the issue with the product?
The affected lots of Potassium Chloride Injection 20 mEq feature an incorrect overwrap labeling identifying the product as 10 mEq. This discrepancy arose during manufacturing, as reported by Otsuka ICU Medical LLC. The dosage is correctly printed on the primary labeling on the product bag. However, this may not be visible due to the mislabeled overwrap.
If administered according to the incorrect 10 mEq overwrap label, the patient could inadvertently receive twice the intended dose of potassium chloride, leading to hyperkalemia.
Severe hyperkalemia may manifest through symptoms like muscle weakness, paralysis, cardiac dysrhythmias, hypotension, and even cardiac arrest. Certain populations—such as premature infants, patients with renal failure, or those taking potassium-sparing diuretics—are particularly susceptible.
What products are being recalled?
The recall involves the following:
| Product Name | Strength | Lot Number | Expiration Date | NDC |
|---|---|---|---|---|
| Potassium Chloride Injection | 20 mEq | 1030613 | 09-30-2026 | 0990-7077-14 |
Distribution ranges include May 23, 2025 through August 26, 2025. Healthcare providers are urged to check inventory for this lot number and immediately suspend usage.
How can affected products be returned?
Otsuka ICU Medical LLC has communicated the recall to its distributors and customers. If you have affected products, follow these return procedures:
- Contact Sedgwick at 1-888-566-2363 (Monday–Friday, 8am–5pm ET) to obtain a return label.
- Return products to the original place of purchase.
For inquiries or assistance, contact Otsuka ICU Medical LLC through the following:
- Email: globalcomplaints@icumed.com
- Phone: 1-(866)-216-8806 or 1-800-258-5361
Adverse events or quality issues can be reported directly to the FDA’s MedWatch program.
FAQ
- Who is affected by this recall?
Healthcare providers administering Potassium Chloride Injection from the affected lot should cease use and follow return instructions. - What should I do if I have administered the affected product?
If misuse is suspected, monitor patients for signs of hyperkalemia and seek medical advice promptly. - How can I report adverse reactions?
Submit reports to the FDA’s MedWatch program online at www.fda.gov/medwatch/report.htm. - Where can I find more information?
Contact Otsuka ICU Medical LLC or visit the FDA Safety page.
Conclusion
This recall highlights the critical need for accurate labeling to ensure patient safety. Healthcare professionals and distributors are strongly advised to review inventory for the affected lot and immediately halt further use or distribution. Taking proactive steps can prevent adverse events and ensure appropriate medical care for patients.
Disclaimer
This article is for informational purposes only and is not intended as legal or medical advice. Healthcare professionals should consult regulatory guidance for specific instructions and adhere to their local policies.
FDA Announcement
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