FDAFDA recall D-0849-2026 · Sep 9, 2026
Baxter Healthcare Corporation: 0 recall
Recall found
Product
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Reason for recall
Presence of particulate matter: Particulates identified as fiberglass
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot: Y495523, Y495523A, Exp 31-Oct-2027
- Quantity
- 145,464 500mL bags
- Distribution
- Natonwide in the USA
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-17
Source: openFDA enforcement record D-0849-2026 · search recall number D-0849-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.