0.9% SODIUM CHLORIDE Injection recall — Class II (D-0143-2026) · pharmaranks
Class IIOngoing
0.9% SODIUM CHLORIDE Injection recall
FDA recall D-0143-2026 · initiated Oct 27, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Potential for flexible container leaks.
Details
Product
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Recalling company
Otsuka ICU Medical LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Distributed Nationwide in the USA.
Initiated
Oct 27, 2025
FDA report date
Nov 5, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.