FDA Drugs recall ·
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0869-2026
- Date
- (initiated August 19, 2026)
- Company / brand
- B Braun Medical Inc
861 Marcon Blvd, Allentown, PA, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 201,472 total container
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
Distribution
Nationwide within the United States
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0869-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.