0.9% Sodium Chloride Injection USP 500 mL recall
FDA recall D-0849-2026 · initiated Aug 17, 2026
Baxter Healthcare Corporation recalled 0.9% Sodium Chloride Injection USP 500 mL in Aug 2026 — an FDA Class I recall (D-0849-2026) because Presence of particulate matter: Particulates identified as fiberglass.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of particulate matter: Particulates identified as fiberglass
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 145,464 500mL bags
Details
- 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
- Recalling company
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Natonwide in the USA
- Initiated
- Aug 17, 2026
- FDA report date
- Sep 9, 2026
Frequently asked
- Was 0.9% Sodium Chloride Injection USP 500 mL recalled?
- Baxter Healthcare Corporation recalled 0.9% Sodium Chloride Injection USP 500 mL in Aug 2026 — an FDA Class I recall (D-0849-2026) because Presence of particulate matter: Particulates identified as fiberglass. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was 0.9% Sodium Chloride Injection USP 500 mL recalled?
- Per the FDA enforcement record, the reason for recall D-0849-2026 was: Presence of particulate matter: Particulates identified as fiberglass
- Is a recalled 0.9% Sodium Chloride Injection USP 500 mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of 0.9% Sodium Chloride Injection USP 500 mL are affected?
- Distributed: Natonwide in the USA. The recall covers these lots — Lot: Y495523, Y495523A, Exp 31-Oct-2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0849-2026.