Recall archive / FDA company announcement

ICU Medical: 20 mEq Potassium Chloride Injection — FDA announcement Nov 3, 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 Nov 3, 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: 20 mEq Potassium Chloride Injection
Reason: Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection
Classification: Not supplied
Recalling firm: Otsuka ICU Medical LLC
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 247b9240aed289b9

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. Otsuka ICU Medical LLC has identified this discrepancy due to a manufacturing issue. The dosage is correctly printed on the labeling affixed to the product bag which is not visible when the 10 mEq OVERWRAP is in place. This notification details the issue and the required steps for you to perform.; The affected product lot was manufactured on 15 April 2025 and distributed in the United States between 23 May 2025 through 26 August 2025. The affected product lot (Located on the top left of the product bag or the case label is:; NDC Number \| List Number \| Product Description \| Lot Number \| Expiration Date \| Configuration; 0990-7077-14 \| 070770452 \| POTASSIUM CHLORIDE Inj. 20 mEq \| 1030613 \| 30 September 2026 \| 50mL in Flexible Container; 0990-7074-26 \| 070740452 \| POTASSIUM CHLORIDE Inj. 10 mEq \| N/A \| N/A \| 100mL in Flexible Container; NDC Number \| Barcode Number \| Lot Number \| Expiration Date \| Configuration; 0990-7077-14 \| (01)20309907077141 \| 1030613 \| 30 September 2026 \| 24/case; Otsuka ICU Medical LLC Contact \| Contact Information \| Areas of Support; Global Complaint Management \| [email protected](866)-216-8806 \| To report product complaints; Drug Safety \| 1-844-654-7780 [email protected] \| To report adverse events for IV Solutions & Drugs; Medical Information \| 1-800-241-4002, option 6 or [email protected] \| Medical inquiries; Customer Care \| [email protected](800)-258-5361 \| Product Credit; Field Action Processing \| [email protected] \| Questions about this action and response forms

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE Inj. 20 mEq, NDC 0990-7077-14. The OVERWRAP label of lot 1030613, Expiration Date: 09-30-2026 may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq with NDC 0990-7074-26. Otsuka ICU Medical LLC has identified this discrepancy due to a manufacturing issue. The dosage is correctly printed on the labeling affixed to the product bag which is not visible when the 10 mEq OVERWRAP is in place. This notification details the issue and the required steps for you to perform.; The affected product lot was manufactured on 15 April 2025 and distributed in the United States between 23 May 2025 through 26 August 2025. The affected product lot (Located on the top left of the product bag or the case label is:; NDC Number | List Number | Product Description | Lot Number | Expiration Date | Configuration; 0990-7077-14 | 070770452 | POTASSIUM CHLORIDE Inj. 20 mEq | 1030613 | 30 September 2026 | 50mL in Flexible Container; 0990-7074-26 | 070740452 | POTASSIUM CHLORIDE Inj. 10 mEq | N/A | N/A | 100mL in Flexible Container; NDC Number | Barcode Number | Lot Number | Expiration Date | Configuration; 0990-7077-14 | (01)20309907077141 | 1030613 | 30 September 2026 | 24/case; Otsuka ICU Medical LLC Contact | Contact Information | Areas of Support; Global Complaint Management | [email protected](866)-216-8806 | To report product complaints; Drug Safety | 1-844-654-7780 [email protected] | To report adverse events for IV Solutions & Drugs; Medical Information | 1-800-241-4002, option 6 or [email protected] | Medical inquiries; Customer Care | [email protected](800)-258-5361 | Product Credit; Field Action Processing | [email protected] | Questions about this action and response forms

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	List Number	Product Description	Lot Number	Expiration Date	Configuration
0990-7077-14	070770452	POTASSIUM CHLORIDE Inj. 20 mEq	1030613	30 September 2026	50mL in Flexible Container
0990-7074-26	070740452	POTASSIUM CHLORIDE Inj. 10 mEq	N/A	N/A	100mL in Flexible Container

FDA company announcement, table 2
NDC Number	Barcode Number	Lot Number	Expiration Date	Configuration
0990-7077-14	(01)20309907077141	1030613	30 September 2026	24/case

FDA company announcement, table 3
Otsuka ICU Medical LLC Contact	Contact Information	Areas of Support
Global Complaint Management	[email protected](866)-216-8806	To report product complaints
Drug Safety	1-844-654-7780 [email protected]	To report adverse events for IV Solutions & Drugs
Medical Information	1-800-241-4002, option 6 or [email protected]	Medical inquiries
Customer Care	[email protected](800)-258-5361	Product Credit
Field Action Processing	[email protected]	Questions about this action and response forms

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

The affected product lot was manufactured on 15 April 2025 and distributed in the United States between 23 May 2025 through 26 August 2025. The affected product lot (Located on the top left of the product bag or the case label is:

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Nov 3, 2025
Company announcement date: Oct 31, 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.