FDA Drugs recall ·
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc… recall
- Recall number
- D-0143-2026
- Date
- (initiated October 27, 2025)
- Company / brand
- Otsuka ICU Medical LLC
3900 Howard Ln, Austin, TX, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 509,360 100 mL bags
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Why was it recalled?
Lack of Assurance of Sterility: Potential for flexible container leaks.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 1029921, Exp Date: 28 February 2027
Distribution
Distributed Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0143-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.