CLASS I ONGOING Drug recall · Reported 10 Sep 2025 · FDA Enforcement Report
0.9% Sodium Chloride Injection USP container recalled by B Braun Medical
B Braun Medical is recalling 0.9% Sodium Chloride Injection USP container, distributed nationwide in the US. The recall was initiated on 18 Aug 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0628-2025
- FDA event ID
- 97433
- Recalling firm
- B Braun Medical, Allentown, PA
- Brand
- Sodium Chloride
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 18 Aug 2025
- FDA classified
- 10 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Aug 2025 | Recall initiated by company | |
| 10 Sep 2025 | Classified by FDA | +23 days |
| 10 Sep 2025 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter.
Product as listed by the FDA
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter.
Which lots are affected?
Lot #: V3K770, Exp 1/31/2026
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97433| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Lactated Ringers's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
More recalls from B Braun Medical
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Sodium Chloride recalls
All 133| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide |