0.9% Sodium chloride Irrigation USP recall
FDA recall D-0353-2025 · initiated Mar 31, 2025
B. Braun Medical Inc recalled 0.9% Sodium chloride Irrigation USP in Mar 2025 — an FDA Class II recall (D-0353-2025) because Presence of Particulate Matter.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter
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: 32,256 Bottles
Details
- Product
- 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
- Recalling company
- B Braun Medical
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 12 distributors who may have further distributed the product nationwide.
- Initiated
- Mar 31, 2025
- FDA report date
- Apr 16, 2025
Frequently asked
- Was 0.9% Sodium chloride Irrigation USP recalled?
- B. Braun Medical Inc recalled 0.9% Sodium chloride Irrigation USP in Mar 2025 — an FDA Class II recall (D-0353-2025) because Presence of Particulate Matter. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was 0.9% Sodium chloride Irrigation USP recalled?
- Per the FDA enforcement record, the reason for recall D-0353-2025 was: Presence of Particulate Matter
- Is a recalled 0.9% Sodium chloride Irrigation USP 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 Irrigation USP are affected?
- Distributed: Product was distributed to 12 distributors who may have further distributed the product nationwide.. The recall covers these lots — Lot # J4K936, Exp 7/31/2027. 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-0353-2025.