# Major Recall Alert: 20 mEq Potassium Chloride Injection Recalled Due to Potential Overdose Risk
Otsuka ICU Medical LLC has issued a voluntary nationwide recall of their **20 mEq Potassium Chloride Injection** due to a serious labeling error that could lead to a dangerous overdose. The product, intended for potassium supplementation, is mislabeled and poses significant health risks to patients, including severe **hyperkalemia**, cardiac arrhythmias, or even death. Here's everything you need to know about this recall and how to stay safe.
## Why This Recall is Important
Potassium chloride injections are critical for treating potassium deficiency in patients unable to tolerate oral supplements. However, **mislabeled dosages pose an extreme health risk**, especially to vulnerable patients such as:
- Premature infants
- Patients with **cardiac arrhythmias**
- Individuals with **renal insufficiency or failure**
- Those on potassium-sparing diuretics
The affected lot of the 20 mEq Potassium Chloride Injection is incorrectly labeled as a **10 mEq dosage on the outer overwrap**, despite the internal product labeling showing the correct dosage. Administering a higher dosage than recommended can cause severe **hyperkalemia**, which may lead to neuromuscular dysfunction, cardiac issues, or even **cardiac arrest**.
The U.S. Food and Drug Administration (FDA) has been notified of this recall to protect consumers.
## Details of the Recall
Otsuka ICU Medical LLC has officially recalled **lot 1030613, Expiration Date: 09-30-2026**, which was distributed in the U.S. between **May 23, 2025, and August 26, 2025**. Key details of the mislabeled product include:
- **Recalled product**: Potassium Chloride Injection 20 mEq
- **Incorrect overwrap label**: Labeled as Potassium Chloride Injection 10 mEq
- **NDC numbers**:
- Correct 20 mEq product NDC: 0990-7077-14
- Incorrect 10 mEq overwrap NDC: 0990-7074-26
This recall stems from a manufacturing error where the external label of the overwrap does not match the actual product dosage. While the interior product bag is labeled correctly, this label is not visible until the overwrap is removed, which can easily lead to dosage errors.
### Potential Risks of Overdose
Using the 10 mEq overwrap label for dosing instead of the actual **20 mEq dosage** can result in an overdose of potassium chloride, potentially causing:
- **Muscle weakness**
- Ascending paralysis
- Mental confusion or vertigo
- Cardiac dysrhythmias
- Death from **cardiac arrest**
To date, **no adverse events related to this issue have been reported**, but all users must take immediate precautions.
## What You Should Do
If you have the affected product or are a distributor, it’s critical to take these steps:
1. **Stop using the product immediately** and set it aside.
2. Contact Sedgwick at **1-888-566-2363** (Mon-Fri, 8 AM to 5 PM ET) to arrange the return of the recalled product and obtain a return label.
3. Healthcare providers should monitor patients for signs of hyperkalemia, if the product may have been used in error.
Anyone experiencing adverse reactions or quality issues with this product should report them to the **FDA MedWatch Adverse Event Reporting program** via phone, fax, mail, or online.
For further details, visit the official **FDA recall announcement** [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due).
## Stay Safe – Get Instant Recall Alerts
Product recalls like this highlight the importance of staying informed about potential dangers in healthcare. Be vigilant when handling injectable potassium chloride and ensure that product labeling is accurate before administering.
For easy, real-time recall notifications, **download our app today** and never miss critical safety alerts about the medications and products your patients rely on. Protect yourself, your patients, and your loved ones with reliable recall updates at your fingertips.
Make safety a priority—**stay updated, stay informed**!