--- title: "ICU Medical: 20 mEq Potassium Chloride Injection — FDA announcement Nov 3, 2025 | Is It on Recall" description: "Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection" url: https://isitonrecall.com/recall/fdapress-247b9240aed289b9-icu-medical-20-meq-potassium-chloride-injection/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA company announcement # ICU Medical: 20 mEq Potassium Chloride Injection — FDA announcement Nov 3, 2025 Published notice; closure not supplied A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing. Source date Nov 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 20 mEq Potassium Chloride Injection - **Reason**: Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection - **Classification**: Not supplied - **Recalling firm**: Otsuka ICU Medical LLC - **Quantity**: Not supplied - **Agency-reported status**: Company recall announcement - **Source record identifier**: 247b9240aed289b9 [Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due) ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. Otsuka ICU Medical LLC has identified this discrepancy due to a manufacturing issue. The dosage is correctly printed on the labeling affixed to the product bag which is not visible when the 10 mEq OVERWRAP is in place. This notification details the issue and the required steps for you to perform.; The affected product lot was manufactured on 15 April 2025 and distributed in the United States between 23 May 2025 through 26 August 2025. The affected product lot (Located on the top left of the product bag or the case label is:; NDC Number \| List Number \| Product Description \| Lot Number \| Expiration Date \| Configuration; 0990-7077-14 \| 070770452 \| POTASSIUM CHLORIDE Inj. 20 mEq \| 1030613 \| 30 September 2026 \| 50mL in Flexible Container; 0990-7074-26 \| 070740452 \| POTASSIUM CHLORIDE Inj. 10 mEq \| N/A \| N/A \| 100mL in Flexible Container; NDC Number \| Barcode Number \| Lot Number \| Expiration Date \| Configuration; 0990-7077-14 \| (01)20309907077141 \| 1030613 \| 30 September 2026 \| 24/case; Otsuka ICU Medical LLC Contact \| Contact Information \| Areas of Support; Global Complaint Management \| globalcomplaints@icumed.com1-(866)-216-8806 \| To report product complaints; Drug Safety \| 1-844-654-7780 orDrugSafety@icumed.com \| To report adverse events for IV Solutions & Drugs; Medical Information \| 1-800-241-4002, option 6 or medinfo\_us@icumed.com \| Medical inquiries; Customer Care \| customerservice@icumed.com1-(800)-258-5361 \| Product Credit; Field Action Processing \| marketaction@mailac.custhelp.com \| Questions about this action and response forms | Match all identifying details in the current notice. A brand name alone is not enough. ## Product tables from the announcement These identifying details come from the company announcement posted by FDA. Check the current notice for revisions. **FDA company announcement, table 1** | NDC Number | List Number | Product Description | Lot Number | Expiration Date | Configuration | | --- | --- | --- | --- | --- | --- | | 0990-7077-14 | 070770452 | POTASSIUM CHLORIDE Inj. 20 mEq | 1030613 | 30 September 2026 | 50mL in Flexible Container | | 0990-7074-26 | 070740452 | POTASSIUM CHLORIDE Inj. 10 mEq | N/A | N/A | 100mL in Flexible Container | **FDA company announcement, table 2** | NDC Number | Barcode Number | Lot Number | Expiration Date | Configuration | | --- | --- | --- | --- | --- | | 0990-7077-14 | (01)20309907077141 | 1030613 | 30 September 2026 | 24/case | **FDA company announcement, table 3** | Otsuka ICU Medical LLC Contact | Contact Information | Areas of Support | | --- | --- | --- | | Global Complaint Management | globalcomplaints@icumed.com1-(866)-216-8806 | To report product complaints | | Drug Safety | 1-844-654-7780 orDrugSafety@icumed.com | To report adverse events for IV Solutions & Drugs | | Medical Information | 1-800-241-4002, option 6 or medinfo\_us@icumed.com | Medical inquiries | | Customer Care | customerservice@icumed.com1-(800)-258-5361 | Product Credit | | Field Action Processing | marketaction@mailac.custhelp.com | Questions about this action and response forms | Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due). ## Distribution The affected product lot was manufactured on 15 April 2025 and distributed in the United States between 23 May 2025 through 26 August 2025. The affected product lot (Located on the top left of the product bag or the case label is: No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Fda listing date**: Nov 3, 2025 - **Company announcement date**: Oct 31, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-20-meq-potassium-chloride-injection-due) ## Before changing a medicine Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine. Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do) ## Related records [Medications records](https://isitonrecall.com/category/medications/) [Otsuka ICU Medical LLC records](https://isitonrecall.com/brand/otsuka-icu-medical-llc/)