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

Potassium Chloride Inj., 20 mEq total in flexible container recalled

ICU Medical is recalling Potassium Chloride Inj., 20 mEq total in flexible container, 200 mEq/L, 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 recalled67,488 flexible containers

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-0267-2025
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: Labeling Errors
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. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

Product as listed by the FDA

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

This product is part of a recall event; the main page for the event is Potassium Chloride Inj., 10 mEq total recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025	CLASS I	Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride	ICU Medical	Other	Nationwide

More recalls from ICU Medical

All 654

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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., 10 mEq total recalled by ICU MedicalPotassium Chloride	ICU Medical	Other	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