Class IDrug
0.9% Sodium Chloride Injection USP 500 mL recall
Summary
Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP 500 mL (drug). According to the FDA report, the reason is: Presence of particulate matter: Particulates identified as fiberglass. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
Baxter is recalling 0.9% Sodium Chloride Injection (500 mL VIAFLEX bags) because particles identified as fiberglass were found.
Why it matters
Medicines given by injection or IV go straight into the bloodstream, so they must be free of visible and sub-visible particles. Particles such as glass, metal or plastic in an injectable can, in principle, block small blood vessels or cause irritation, inflammation or clots. That risk is why the FDA treats particulate matter in injectables seriously.
Who should pay attention
Hospital, clinic and pharmacy staff who use 500 mL saline bags.
Distribution in the FDA report: Natonwide in the USA
How to check your product
Check the lot number and expiration date on the bag and case.
Codes listed by the FDA: Lot: Y495523, Y495523A, Exp 31-Oct-2027
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- 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
- Presence of particulate matter: Particulates identified as fiberglass
- Lot / code info
- Lot: Y495523, Y495523A, Exp 31-Oct-2027
- Quantity
- 145,464 500mL bags
- Distribution
- Natonwide in the USA
- Recalling company
- Baxter Healthcare Corporation, Deerfield, IL United States
- Recall started
- August 17, 2026
- FDA report date
- September 9, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0849-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Baxter Healthcare Corporation) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.