Sodium Chloride Recall: ICU Medical Lot 1029921
Announced 2025-11-26 · FDA
FDA is recalling 0.9% Sodium Chloride Injection, USP, 100 mL bags sold nationwide. The recall is due to lack of assurance of sterility and potential leaks from the flexible container. Lot 1029921 (Exp Date: 28 February 2027) covers 509,360 bags distributed across the United States (NDC 0990-7984-37).
| Brand | 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. |
| Severity | moderate |
| Units affected | 509,360 100 mL bags |
| Distribution | Distributed Nationwide in the USA. |
| Agency | FDA |
| Recall / campaign no. | Lot # 1029921, Exp Date: 28 February 2027 |
WHAT YOU SHOULD DO
- Do not use any 0.9% Sodium Chloride Injection from Lot 1029921.
- If you have units from this lot, stop using them and contact your healthcare provider or supplier for disposal or replacement instructions.
- Follow the supplier's or healthcare provider's instructions for return or replacement of recalled product.
- If you experience any adverse effects or have used the product, contact a healthcare professional and report adverse events to the FDA MedWatch program.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.