Baxter Healthcare Corporation drug recall: 0.9% Sodium Chloride Injection USP 500 mL
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99678
- Recall initiated
- Aug 17, 2026
- Classified by FDA
- Sep 15, 2026
- Posted in Enforcement Report
- Sep 9, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Presence of particulate matter: Particulates identified as fiberglass
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 17, 2026. FDA classified it 29 days later, on Sep 15, 2026. Distribution reported by FDA: Natonwide in the USA Baxter Healthcare Corporation has 279 recalls in our records.
Recalled products (1)
D-0849-2026 Class I Ongoing
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
Codes / lots: Lot: Y495523, Y495523A, Exp 31-Oct-2027
Quantity: 145,464 500mL bags
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 99678
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.