Baxter Healthcare recall: 0.9% Sodium Chloride Injection USP
Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP – 145,464 500mL bags. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 17, 2026. Distributed Natonwide in the USA.
Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.
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| Product | 0.9% Sodium Chloride Injection USP |
| Brand | Baxter Healthcare |
| Company | Baxter Healthcare Corporation |
| Type | Drugs |
| Classification | Class I |
| Recall date | August 17, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 145,464 500mL bags |
| Recall ID | 99678 |
Recalled products
- 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
- FDA recall number
- D-0849-2026
- Codes, lots and dates
- Lot: Y495523, Y495523A, Exp 31-Oct-2027
- Quantity
- 145,464 500mL bags
- Classification
- Class I
Identifiers and details
- FDA event ID
- 99678
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Deerfield, IL, United States
Why it was recalled
The reason the FDA lists: “Presence of particulate matter: Particulates identified as fiberglass”
Where it was sold
Distribution as the FDA records it: “Natonwide in the USA”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99678, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Baxter Healthcare recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  Baxter Healthcare recall: Volara, HC, Na aMedical devices · 2 | Contamination within the release test equipment flow path could have affected the accuracy… Serious | FDA Class II |
| Sep 30, 2026 | Baxter Healthcare recall: Pro+ MRS Surface for Versacare and 2 more productsMedical devices · 169 units; 824 units; 6 units | There is an error in the product description on the Unique Device Identification (UDI) lab… Serious | FDA Class II |
| Sep 16, 2026 |  Baxter Healthcare recall: Dextrose InjectionDrugs · 606 bags | Presence of Particulate Matter: particulate matter identified as stainless steel particles… Most serious | FDA Class I |
| Sep 9, 2026 | Baxter Healthcare recall: Baxter Novum IQ Syringe PumpMedical devices · 14601 units; 4 units | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a s… Serious | FDA Class II |
| Sep 9, 2026 | Baxter Healthcare recall: Vancomycin Injection and 10 more productsDrugs · N/A | manufacturing-practice violations Serious | FDA Class II |
| Aug 19, 2026 | Baxter Healthcare recall: Baxter Duo-Vent Solution Set and Male Luer Lock AdapterMedical devices · 24528 units | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pres… Most serious | FDA Class I |
| Aug 19, 2026 | Baxter Healthcare recall: Cefazolin in DextroseDrugs · 19,032 bags | Presence of Particulate Matter Most serious | FDA Class I |
All 8 Baxter Healthcare recalls →
About this recall
Is Baxter Healthcare 0.9% Sodium Chloride Injection USP recalled?
Yes. Baxter Healthcare Corporation recalled it on August 17, 2026; FDA published it September 9, 2026 (Class I). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Presence of particulate matter: Particulates identified as fiberglass
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Natonwide in the USA.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.