FDA Drugs recall ·
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0628-2025
- Date
- (initiated August 18, 2025)
- Company / brand
- B Braun Medical Inc
861 Marcon Blvd, Allentown, PA, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 47,148 containers
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Why was it recalled?
Presence of Particulate Matter.
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 #: V3K770, Exp 1/31/2026
Distribution
U.S.A. Nationwide
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-0628-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.