0.9% Sodium Chloride Injection recall
FDA recall D-0869-2026 · initiated Aug 19, 2026
B BRAUN MEDICAL INC recalled 0.9% Sodium Chloride Injection in Aug 2026 — an FDA Class I recall (D-0869-2026) because Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
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: 201,472 total container
Details
- Product
- 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
- Recalling company
- B Braun Medical
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Aug 19, 2026
- FDA report date
- Sep 16, 2026
Frequently asked
- Was 0.9% Sodium Chloride Injection recalled?
- B BRAUN MEDICAL INC recalled 0.9% Sodium Chloride Injection in Aug 2026 — an FDA Class I recall (D-0869-2026) because Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was 0.9% Sodium Chloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0869-2026 was: Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Is a recalled 0.9% Sodium Chloride Injection 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 are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.. 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-0869-2026.