---
title: "ICU Medical LLC: 0.9% Sodium Chloride Injection, USP, 100 mL — FDA announcement Sep 21, 2026 | Is It on Recall"
description: "Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection"
url: https://isitonrecall.com/recall/fdapress-2074d1211e5be838-icu-medical-llc-0-9-sodium-chloride-injection-usp-100-ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# ICU Medical LLC: 0.9% Sodium Chloride Injection, USP, 100 mL — FDA announcement Sep 21, 2026

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 Sep 21, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 0.9% Sodium Chloride Injection, USP, 100 mL
- **Reason**: Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 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**: 2074d1211e5be838

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-due)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | September 17, 2026 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj. 10 mEq, (NDC 0990-7074-26) Lot 1035181. The issue has been identified through a customer complaint where a 10 mEq Highly Concentrated POTASSIUM CHLORIDE Injection 100 mL bag was found inside an overwrap of 0.9% SODIUM CHLORIDE Injection, USP 100 mL.; Affected Product: The affected product lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026. An image of the overwrap and the mixed-up product is provided below. Please note that the incorrect product being overwrapped with a Sodium Chloride overwrap contains its own label and clearly indicates it to be POTASSIUM CHLORIDE Inj. 10 mEq. The affected product information is provided in Table 1 below:; NDC Number \| List Number \| Product Description \| Lot Number \| Expiration Date \| Configuration \| Label Example; 0990-7984-23 \| 07984-23 \| 0.9% SODIUM CHLORIDE Injection, USP \| 1042188 \| 31 October 2027 \| 100 mL in flexible container \| See below; NDC Number \| Barcode Number GTIN \| Lot Number \| Expiration Date \| Configuration; 0990-7984-23 \| (01)30309907984231 \| 1042188 \| 31 October 2027 \| 100 mL in flexible container; ICU Medical Contact \| Contact Information \| Areas of Support; Global Complaint Management \| 1-(866)-216-8806 or globalcomplaints@icumed.com \| Reporting product complaints; Drug Safety \| 1-844-654-7780 or DrugSafety@icumed.com \| Reporting adverse events for IV Solutions & Drugs; Medical Information \| 1-800-241-4002, option 6 or medinfo\_us@icumed.com \| Medical inquiries; Customer Care \| 1-(800)-258-5361 or customerservice@icumed.com \| Product credit Return instructions; Field Action Processing \| marketaction@mailac.custhelp.com \| 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 | Label Example |
| --- | --- | --- | --- | --- | --- | --- |
| 0990-7984-23 | 07984-23 | 0.9% SODIUM CHLORIDE Injection, USP | 1042188 | 31 October 2027 | 100 mL in flexible container | See below |

**FDA company announcement, table 2**

| NDC Number | Barcode Number GTIN | Lot Number | Expiration Date | Configuration |
| --- | --- | --- | --- | --- |
| 0990-7984-23 | (01)30309907984231 | 1042188 | 31 October 2027 | 100 mL in flexible container |

**FDA company announcement, table 3**

| ICU Medical Contact | Contact Information | Areas of Support |
| --- | --- | --- |
| Global Complaint Management | 1-(866)-216-8806 or globalcomplaints@icumed.com | Reporting product complaints |
| Drug Safety | 1-844-654-7780 or DrugSafety@icumed.com | Reporting adverse events for IV Solutions & Drugs |
| Medical Information | 1-800-241-4002, option 6 or medinfo\_us@icumed.com | Medical inquiries |
| Customer Care | 1-(800)-258-5361 or customerservice@icumed.com | Product credit Return instructions |
| Field Action Processing | marketaction@mailac.custhelp.com | Questions about this action and response forms |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-due).

## Distribution

Affected Product: The affected product lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026. An image of the overwrap and the mixed-up product is provided below. Please note that the incorrect product being overwrapped with a Sodium Chloride overwrap contains its own label and clearly indicates it to be POTASSIUM CHLORIDE Inj. 10 mEq. The affected product information is provided in Table 1 below:

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

## Dates in the source

- **Fda listing date**: Sep 21, 2026
- **Company announcement date**: Sep 17, 2026

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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/otsuka-icu-medical-llc-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-due)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Otsuka ICU Medical LLC records](https://isitonrecall.com/brand/otsuka-icu-medical-llc/)