CLASS I ONGOING Drug recall · Reported 19 Mar 2025 · FDA Enforcement Report

Potassium Chloride Inj., 10 mEq total recalled by ICU Medical

ICU Medical is recalling Potassium Chloride Inj., 10 mEq total in, 100 mEq/L flexible container, distributed nationwide in the US. The recall was initiated on 13 Feb 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot 1023172, Exp Date: 31 January 2026

NDC0990-7074, 0990-7075, 0990-7077

Quantity recalledunknown

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0268-2025
FDA event ID: 96250
Recalling firm: ICU Medical, Lake Forest, IL
Brand: Potassium Chloride
Manufacturer: ICU Medical Inc.
Classification: Class I
Status: Ongoing
Recall initiated: 13 Feb 2025
FDA classified: 10 Mar 2025
Reported: 19 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Injectable & IV Drugs

Timeline

13 Feb 2025	Recall initiated by company
10 Mar 2025	Classified by FDA	+25 days
19 Mar 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

Product as listed by the FDA

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

Which lots are affected?

Lot 1023172, Exp Date: 31 January 2026

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96250

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025	CLASS I	Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride	ICU Medical	Labeling Errors	Nationwide

More recalls from ICU Medical

All 654

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

Other Potassium Chloride recalls

All 23

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
26 Nov 2025Drug	CLASS I	Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride	Otsuka ICU Medical	Other	Nationwide
19 Mar 2025Drug	CLASS I	Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride	ICU Medical	Labeling Errors	Nationwide
12 Feb 2025Drug	CLASS II	Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride	The Harvard Drug Group	Potency & Assay	Nationwide
7 Aug 2024Drug	CLASS I	Potassium Chloride Extended-Release Capsules recalledPotassium Chloride	Amerisource Health Services	Potency & Assay	Nationwide