FDA Recall Sodium Chloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on August 2nd, 2023 and classified as a Class III recall due to labeling: not elsewhere classified - the description, warnings, storage information and instructions for use are either missing or partially printed. This recall is currently terminated, and the associated recall number is recall number is D-1083-2023. It pertains to Sodium Chloride identified by 0264-5802 as of 07-07-2025 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-1083-2023 | 08-02-2023 | 08-16-2023 | 43,812 bags | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 | Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed. | Terminated |
| D-0916-2023 | 07-05-2023 | 07-19-2023 | 79,880 bags | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00 | Lack of assurance of sterility: bags have the potential to leak. | Terminated |
| D-0346-2023 | 02-10-2023 | 03-01-2023 | 1,343,982 bags | 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | Ongoing |
| D-0347-2023 | 02-10-2023 | 03-01-2023 | 483,229 bags | 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10 | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product. | Ongoing |
| D-0076-2023 | 11-25-2022 | 12-14-2022 | 756 bags | 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 | Lack of sterility assurance: Bags have the potential to leak. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
