0.9% Sodium Chloride Injection (2,250 mg) Recall: Sterility Concern
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was 0.9% Sodium Chloride Injection recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
Which lot codes, UPCs or models are affected?
Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.
- Agency record number
- D-0427-2026
- Product
- 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius…
- Recalling firm
- Fresenius Kabi USA, LLC
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Recall started
- March 11, 2026
- Report date
- April 15, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)