Baxter Recalls Sodium Chloride Injections Due to Insect Contamination
Baxter Healthcare recalls 255,852 bags of 0.9% Sodium Chloride Injection due to confirmed insect particulate matter in the primary container.
Stop using this now
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Contact the company
What happened, in plain English
Baxter Healthcare Corporation is recalling 255,852 VIAFLEX Plastic Container Bags of 0.9% Sodium Chloride Injection, USP because customers have reported finding an insect floating inside the bag. This is a Class I recall, indicating a situation where use of the product could cause serious adverse health consequences or death. The specific lot involved is C980227 with an expiration date of 11/16. Read more at govinfonow.com/recall/43324-baxter-recalls-sodium-chloride-injections-due-to-insect-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/43324-baxter-recalls-sodium-chloride-injections-due-to-insect-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-0957-2016
Cite this page
“Baxter Recalls Sodium Chloride Injections Due to Insect Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43324-baxter-recalls-sodium-chloride-injections-due-to-insect-contamination. Based on FDA recall #D-0957-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0957-2016%22&limit=1).
Why it’s dangerous
The primary container of the injection bag contains confirmed particulate matter in the form of an insect. Introducing foreign objects into a sterile medical solution intended for direct entry into the bloodstream poses a severe risk of infection, embolism, or other serious health complications.
Who’s affected
Patients and medical facilities in the United States who have received or are using the recalled Baxter Sodium Chloride Injection bags. The risk applies to anyone who might receive this contaminated product for intravenous use.
How to tell if you have this one
Check if you have 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bags manufactured by Baxter Healthcare Corporation. Look for NDC 0338-0049-02 and Lot # C980227 with an expiration date of 11/16.
- Brand
Baxter Healthcare- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0957-2016 | 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02; Lot # C980227; Exp. 11/16 | 255,852 VIAFLEX Plastic Containers | 0338-0049-01, 0338-0049-02, 0338-0049-03, 0338-0049-04, 0338-0049-10, 0338-0049-41, 0338-0049-11, 0338-0049-31, 0338-0049-48, 0338-0049-18, 0338-0049-38, 0338-0043-03, 0338-0043-04 |
| D-0958-2016 | Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06; Lot # C985150; Exp. 07/16 | 28,080 VIAFLEX Plastic Containers | 0338-0719-06 |
What to do — step by step
Stop Using the Product
Do not use any bags matching the recalled lot number or NDC due to the risk of serious injury from insect contamination.
Contact Your Supplier
Reach out to your pharmacy or medical supplier to report the issue and arrange for a replacement or return, as the remedy details are not explicitly stated in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0957-2016 (December 15, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0957-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.