FDA Recall D-0143-2026
Otsuka ICU Medical LLC · Austin, TX
Class II Ongoing 199 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0143-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA.
- Recall initiated
- 2025-10-27
- Classified by FDA Center
- 2025-10-30
- FDA published
- 2025-11-05
- Recalling firm
- Otsuka ICU Medical LLC
- Firm location
- Austin, TX
Drug identification
- Brand name(s)
- SODIUM CHLORIDE
- Generic name(s)
- SODIUM CHLORIDE
- Manufacturer(s)
- ICU Medical Inc.
- NDC(s)
0990-7730, 0990-7983, 0990-7984, 0990-7985- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.