Otsuka ICU Medical LLC recalls 0.9% SODIUM CHLORIDE Injection
- Recalling company
- Otsuka ICU Medical LLC
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Oct 27, 2025
- Reported
- Nov 5, 2025
- Distribution
- Distributed Nationwide in the USA.
- Status
- Ongoing
- Quantity
- 509,360 100 mL bags
- Lot / codes
- Lot # 1029921, Exp Date: 28 February 2027
- Company location
- Austin, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0143-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0143-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.