0 — Class II drug recall D-0143-2026
Ongoing recall by Otsuka ICU Medical LLC, reported 2025-11-05, distributed nationwide. Lack of Assurance of Sterility: Potential for flexible container leaks.
| Recall number | D-0143-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Otsuka ICU Medical LLC, Austin, TX, United States |
| Recall initiated | 2025-10-27 |
| Classified | 2025-10-30 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 509,360 |
| Reason classes | sterility, packaging |
| NDC | 00990-7730, 00990-7730-36, 00990-7730-37, 00990-7983, 00990-7983-02, 00990-7983-03, 00990-7983-09, 00990-7983-53, 00990-7983-55, 00990-7983-61, 00990-7984, 00990-7984-13, 00990-7984-20, 00990-7984-23, 00990-7984-36, 00990-7984-37, 00990-7985, 00990-7985-02, 00990-7985-03, 00990-7985-09 |
| Lot numbers | 1029921 |
| Expiration dates | 2027-02-28 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0143-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.