Highest risk U.S. Food and Drug Administration

ICU Medical Potassium Chloride Inj. 20 mEq and 10 mEq recall: Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels

Recall published 1+ years ago

Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.

ICU Medical Prescription & OTC drugs — recalled prescription & otc drugsICU Medical Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)ICU Medical Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)ICU Medical Prescription & OTC drugs — recalled prescription & otc drugs (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
February 13, 2025
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
ICU Medical
Product type
Prescription & OTC drugs
UPC codes
00309907074269, 00309907075266, 30309907075267

Products covered by this recall

POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq

What the company announced

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

Risk Statement: If the Health Care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride. Severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes. ICU Medical has not received reports of adverse events associated with this issue to date.

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.

DESCRIPTION OF MISLABELLED BAGS BEING RECALLED:

  • NDC Number: 0990-7074-26 · Barcode Number: (01)00309907074269 · Product Overwrap Description: POTASSIUM CHLORIDE Inj. 10 mEq · Product Primary Bag Description: POTASSIUM CHLORIDE Inj. 20 mEq · Lot Number: 1023172 · Expiration Date: 31 January 2026 · Configuration: 100 mL Flexible Container
  • NDC Number: 0990-7075-26 · Barcode Number: (01)00309907075266 · Product Overwrap Description: POTASSIUM CHLORIDE Inj. 20 mEq · Product Primary Bag Description: POTASSIUM CHLORIDE Inj. 20 mEq · Lot Number: 1023172 · Expiration Date: 31 January 2026 · Configuration: 100 mL Flexible Container

DESCRIPTION OF CASES BEING RECALLED:

  • NDC Number: 0990-7075-26 · Barcode Number: (01)30309907075267 · Lot Number: 1023172 · Expiration Date: 31 January 2026 · Configuration: 1 x 24 – 100 mL

ICU Medical is notifying its customers, including distributors, of this recall by letter, and is arranging for the return of all recalled product. All Health Care professionals that have product that is being recalled should stop use/further distribution, as applicable, and return to place of purchase.

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.

For further inquiries, please contact ICU Medical using the information provided below

  • ICU Medical Contact: Global Complaint Management · Contact Information: 1-844-654-7780 or [email protected] M-F 8-5 CST · Areas of Support: To report product complaints
  • ICU Medical Contact: Drug Safety · Contact Information: 1-844-654-7780 or [email protected] M-F 8-5 CST · Areas of Support: To report adverse events for IV Solutions & Drugs
  • ICU Medical Contact: Medical Information · Contact Information: 1-800-241-4002, option 6 or [email protected] M-F 8-5 CST · Areas of Support: Medical inquiries
  • ICU Medical Contact: Customer Care · Contact Information: 1-877-946-7747, option 1 M-F 7-6 CST · Areas of Support: Product Replacement Options

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00309907074269
  • 00309907075266
  • 30309907075267

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 1023172

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 31 January 2026
  • 2026-01

NDC number

On the carton and again on the bottle or blister label.

  • 0990-7074-26
  • 0990-7075-26

Package size

Match the net weight or the piece count on the front of the pack.

  • 100 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

ICU Medical — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  3. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  4. Check the lot code on your pack — these mix-ups are usually confined to a short production window.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: 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.

Company contact: ICU Medical — Consumers: Customer Care, 1-877-946-7747, option 1 — Media: Global Complaint Management, 1-844-654-7780, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was ICU Medical prescription & otc drugs recalled?

Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00309907074269, 00309907075266, 30309907075267; lot code 1023172; best-by date 31 January 2026 or 2026-01. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

The notice says: 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.

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