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Drug FDA Class II Ongoing Contamination / non-sterility

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

Otsuka ICU Medical LLC Published Nov 5, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Otsuka ICU Medical LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Lack of Sterility Assurance due to Container Leaks · primary

Affected products (1)

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

SODIUM CHLORIDE · 509,360 100 mL bags

NDC: 0990-7730, 0990-7983, 0990-7984, 0990-7985, 0990-7730-36, 0990-7730-37, 0990-7983-61, 0990-7983-02, 0990-7983-03, 0990-7983-09, 0990-7983-55, 0990-7983-53, 0990-7984-37, 0990-7984-20, 0990-7984-13, 0990-7984-23, 0990-7984-36, 0990-7985-02, 0990-7985-03, 0990-7985-09
Lot codes: 1029921
Code info: Lot # 1029921, Exp Date: 28 February 2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 27, 2025
  2. Published
    Nov 5, 2025
Recall number
D-0143-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.