Recall archive / 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. Source coverage and dates.

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

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 [email protected] \| Reporting product complaints; Drug Safety \| 1-844-654-7780 or [email protected] \| Reporting adverse events for IV Solutions & Drugs; Medical Information \| 1-800-241-4002, option 6 or [email protected] \| Medical inquiries; Customer Care \| 1-(800)-258-5361 or [email protected] \| Product credit Return instructions; Field Action Processing \| [email protected] \| Questions about this action and response forms

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 [email protected] | Reporting product complaints; Drug Safety | 1-844-654-7780 or [email protected] | Reporting adverse events for IV Solutions & Drugs; Medical Information | 1-800-241-4002, option 6 or [email protected] | Medical inquiries; Customer Care | 1-(800)-258-5361 or [email protected] | Product credit Return instructions; 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	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 [email protected]	Reporting product complaints
Drug Safety	1-844-654-7780 or [email protected]	Reporting adverse events for IV Solutions & Drugs
Medical Information	1-800-241-4002, option 6 or [email protected]	Medical inquiries
Customer Care	1-(800)-258-5361 or [email protected]	Product credit Return instructions
Field Action Processing	[email protected]	Questions about this action and response forms

Announcement retrieved Oct 1, 2026. Official announcement.

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.