FDA Drug recall D-0143-2026
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- FDA Drug
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 by Otsuka Icu Medical, citing lack of Assurance of Sterility: Potential for flexible container leaks.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0143-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-27 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Otsuka Icu Medical |
| Distribution | US |
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.
Identifiers
| ndc | 0990-7730-36 |
|---|---|
| ndc | 0990-7730-37 |
| ndc | 0990-7983-61 |
| ndc | 0990-7983-02 |
| ndc | 0990-7983-03 |
| ndc | 0990-7983-09 |
| ndc | 0990-7983-55 |
| ndc | 0990-7983-53 |
| ndc | 0990-7984-37 |
| ndc | 0990-7984-20 |
| ndc | 0990-7984-13 |
| ndc | 0990-7984-23 |
| ndc | 0990-7984-36 |
| ndc | 0990-7985-02 |
| ndc | 0990-7985-03 |
| ndc | 0990-7985-09 |
| code_info | Lot # 1029921, Exp Date: 28 February 2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0143-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.