0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

FDA recall notice · announced November 5, 2025 · Otsuka Icu Medical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Reason for recall

Lack of Assurance of Sterility: Potential for flexible container leaks.

Notes

Distribution: Distributed Nationwide in the USA.
Lot/code information: Lot # 1029921, Exp Date: 28 February 2027
Quantity: 509,360 100 mL bags
Status: Ongoing
Products in this recall event:
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 (D-0143-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.