Recall archive / 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. Source coverage and dates.

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

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 [email protected] M-F 8-5 CST \| To report product complaints; Drug Safety \| 1-844-654-7780 or [email protected] M-F 8-5 CST \| To report adverse events for IV Solutions & Drugs; Medical Information \| 1-800-241-4002, option 6 or [email protected] M-F 8-5 CST \| Medical inquiries; Customer Care \| 1-877-946-7747, option 1 M-F 7-6 CST \| Product Replacement Options

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 [email protected] M-F 8-5 CST | To report product complaints; Drug Safety | 1-844-654-7780 or [email protected] M-F 8-5 CST | To report adverse events for IV Solutions & Drugs; Medical Information | 1-800-241-4002, option 6 or [email protected] 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 [email protected] M-F 8-5 CST	To report product complaints
Drug Safety	1-844-654-7780 or [email protected] M-F 8-5 CST	To report adverse events for IV Solutions & Drugs
Medical Information	1-800-241-4002, option 6 or [email protected] 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.

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.