Recall archive / FDA drug enforcement

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-... — FDA record D-0143-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 27, 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: 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason: Lack of Assurance of Sterility: Potential for flexible container leaks.
Classification: Class II
Recalling firm: Otsuka ICU Medical LLC
Quantity: 509,360 100 mL bags
Agency-reported status: Ongoing
Source record identifier: D-0143-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot # 1029921, Exp Date: 28 February 2027

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Distributed Nationwide in the USA.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Nov 5, 2025
Recall initiation date: Oct 27, 2025
Center classification date: Oct 30, 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.