--- title: "ICU Medical: POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq — FDA announcement Feb 14, 2025 | Is It on Recall" description: "Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq." url: https://isitonrecall.com/recall/fdapress-d61aa3fb1a5d1f31-icu-medical-potassium-chloride-inj-20-meq-and-10-meq/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA company announcement # ICU Medical: POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq — FDA announcement Feb 14, 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 Feb 14, 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**: POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq - **Reason**: Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. - **Classification**: Not supplied - **Recalling firm**: ICU Medical - **Quantity**: Not supplied - **Agency-reported status**: Company recall announcement - **Source record identifier**: d61aa3fb1a5d1f31 [Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride) ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | FOR IMMEDIATE RELEASE – February 13, 2025 LAKE FOREST, Illinois – ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.; ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V. Bag) of POTASSIUM CHLORIDE due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place; Potassium Chloride Injection 20 mEq and 10 mEq, is indicated in the treatment of potassium deficiency states, when oral replacement is not feasible and is packaged in 100 mL bags. The mislabeled POTASSIUM CHLORIDE Inj. 20 mEq, 100 mL bags contain incorrect overwrap labels with the following information: NDC 0990-7074-26, 200 mEq/L POTASSIUM CHLORIDE Inj. 10 mEq. The lot 1023172 and Exp. Date 31 January 2026 is found on the primary container (see picture below). These mislabeled bags are packaged in cases labeled: NDC 0990-7075-26, CASE PACK 1x24 – 100ML 20MEQ POTASSIUM CHLORIDE INJECTION LOT NO. 1023172, EXP DATE 2026-01.; NDC Number \| Barcode Number \| Product Overwrap Description \| Product Primary Bag Description \| Lot Number \| Expiration Date \| Configuration; 0990-7074-26 \| (01)00309907074269 \| POTASSIUM CHLORIDE Inj. 10 mEq \| POTASSIUM CHLORIDE Inj. 20 mEq \| 1023172 \| 31 January 2026 \| 100 mL Flexible Container; 0990-7075-26 \| (01)00309907075266 \| POTASSIUM CHLORIDE Inj. 20 mEq \| POTASSIUM CHLORIDE Inj. 20 mEq \| 1023172 \| 31 January 2026 \| 100 mL Flexible Container; NDC Number \| Barcode Number \| Lot Number \| Expiration Date \| Configuration; 0990-7075-26 \| (01)30309907075267 \| 1023172 \| 31 January 2026 \| 1 x 24 – 100 mL; ICU Medical Contact \| Contact Information \| Areas of Support; Global Complaint Management \| 1-844-654-7780 or ProductComplaintsPP@icumed.com M-F 8-5 CST \| To report product complaints; Drug Safety \| 1-844-654-7780 or DrugSafety@icumed.com M-F 8-5 CST \| To report adverse events for IV Solutions & Drugs; Medical Information \| 1-800-241-4002, option 6 or medinfo\_us@icumed.com M-F 8-5 CST \| Medical inquiries; Customer Care \| 1-877-946-7747, option 1 M-F 7-6 CST \| Product Replacement Options | 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 | Barcode Number | Product Overwrap Description | Product Primary Bag Description | Lot Number | Expiration Date | Configuration | | --- | --- | --- | --- | --- | --- | --- | | 0990-7074-26 | (01)00309907074269 | POTASSIUM CHLORIDE Inj. 10 mEq | POTASSIUM CHLORIDE Inj. 20 mEq | 1023172 | 31 January 2026 | 100 mL Flexible Container | | 0990-7075-26 | (01)00309907075266 | POTASSIUM CHLORIDE Inj. 20 mEq | POTASSIUM CHLORIDE Inj. 20 mEq | 1023172 | 31 January 2026 | 100 mL Flexible Container | **FDA company announcement, table 2** | NDC Number | Barcode Number | Lot Number | Expiration Date | Configuration | | --- | --- | --- | --- | --- | | 0990-7075-26 | (01)30309907075267 | 1023172 | 31 January 2026 | 1 x 24 – 100 mL | **FDA company announcement, table 3** | ICU Medical Contact | Contact Information | Areas of Support | | --- | --- | --- | | Global Complaint Management | 1-844-654-7780 or ProductComplaintsPP@icumed.com M-F 8-5 CST | To report product complaints | | Drug Safety | 1-844-654-7780 or DrugSafety@icumed.com M-F 8-5 CST | To report adverse events for IV Solutions & Drugs | | Medical Information | 1-800-241-4002, option 6 or medinfo\_us@icumed.com M-F 8-5 CST | Medical inquiries | | Customer Care | 1-877-946-7747, option 1 M-F 7-6 CST | Product Replacement Options | Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride). ## Distribution Not supplied No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Fda listing date**: Feb 14, 2025 - **Company announcement date**: Feb 13, 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 Consumers with questions regarding this recall can contact ICU Medical by phone number or e-mail address as indicated in the table below. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. [Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride) ## 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/) [ICU Medical records](https://isitonrecall.com/brand/icu-medical/)