Medications & Supplements/Prescription Drugs

ICU Medical Potassium Chloride Injection Recalled for Strength Labeling Error

Agency Publication Date: March 10, 2025

Summary

ICU Medical, Inc. is recalling 67,488 units of Potassium Chloride Injection because some bags containing 20 mEq of the medication may be placed in overwraps that incorrectly label the strength as 10 mEq. While the inner bag itself is correctly labeled, hospital staff relying on the outer overwrap might inadvertently administer a double dose of potassium to a patient. This recall affects lot number 1023172 with an expiration date of January 31, 2026.

Risk

Administering 20 mEq of potassium when 10 mEq was intended can lead to hyperkalemia (excessively high potassium levels). This condition can cause serious heart rhythm disturbances or life-threatening cardiac arrest.

What You Should Do

This recall affects ICU Medical Potassium Chloride Injection (20 mEq and 10 mEq strengths) sold in 100 mL flexible containers from lot 1023172.
Identify recalled products by looking for lot number 1023172 and expiration date 2026-01 (January 31, 2026) printed on the packaging.
Check the NDC numbers: the 20 mEq strength is NDC 0990-7075-26 and the 10 mEq strength is NDC 0990-7074-26.
Inspect both the outer overwrap and the inner flexible bag to ensure the dosage strengths match before any administration.
Stop using the recalled product. Contact ICU Medical, Inc. or your distributor immediately to arrange for the return of any affected units.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL

Variants: 200 mEq/L, 20 mEq

Lot Numbers:

1023172 (Exp 31 January 2026)

NDC:

0990-7075-26

GTIN:

00309907075266

30309907075267

Flexible container barcode (01) 00309907075266; Case barcode (01) 30309907075267

Product: POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL

Variants: 100 mEq/L, 10 mEq

Lot Numbers:

1023172 (Exp 31 January 2026)

NDC:

0990-7074-26

GTIN:

00309907074269

Affected by overwrap mislabeling where 20 mEq product may be in a 10 mEq overwrap.

Product Images

“Example Case label 20 MEQ POTASSIUM CHLORIDE INJECTION”

“Image of Mislabeled Overwrap and Product Image”

“Image of Incorrect Overwrap POTASSIUM CHLORIDE INJ. 10 mEq”

“Image of Correct Overwrap POTASSIUM CHLORIDE INJ. 20 mEq”

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96250

Status: Active

Manufacturer: ICU Medical, Inc.

Sold By: Hospitals; Infusion Centers; Wholesale Distributors

Manufactured In: United States

Units Affected: 2 products (67,488 flexible containers; unknown)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects ICU Medical Potassium Chloride Injection (20 mEq and 10 mEq strengths) sold in 100 mL flexible containers from lot 1023172.

Identify recalled products by looking for lot number 1023172 and expiration date 2026-01 (January 31, 2026) printed on the packaging.

Check the NDC numbers: the 20 mEq strength is NDC 0990-7075-26 and the 10 mEq strength is NDC 0990-7074-26.

Inspect both the outer overwrap and the inner flexible bag to ensure the dosage strengths match before any administration.

Stop using the recalled product. Contact ICU Medical, Inc. or your distributor immediately to arrange for the return of any affected units.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Affected Products

Product: POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL

Variants: 200 mEq/L, 20 mEq

Lot Numbers:

1023172 (Exp 31 January 2026)

NDC:

0990-7075-26

GTIN:

00309907075266

30309907075267

Flexible container barcode (01) 00309907075266; Case barcode (01) 30309907075267

Product: POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL

Variants: 100 mEq/L, 10 mEq

Lot Numbers:

1023172 (Exp 31 January 2026)

NDC:

0990-7074-26

GTIN:

00309907074269

Affected by overwrap mislabeling where 20 mEq product may be in a 10 mEq overwrap.