CLASS II ONGOING Drug recall · Reported 29 Apr 2026 · FDA Enforcement Report
Sterile Water for Injection recalled by B Braun Medical
B Braun Medical is recalling Sterile Water for Injection USP, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class II.
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-0495-2026
- FDA event ID
- 98693
- Recalling firm
- B Braun Medical, Allentown, PA
- Brand
- Sterile Water
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Apr 2026
- FDA classified
- 28 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Apr 2026 | Recall initiated by company | |
| 28 Apr 2026 | Classified by FDA | +26 days |
| 29 Apr 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Which lots are affected?
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
Where was it sold?
US 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
3 other products · FDA event 98693This product is part of a recall event; the main page for the event is Dextrose Injection recalled by B Braun Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dextrose Injection recalled by B Braun MedicalDextrose | B Braun Medical | Sterility | Nationwide | |
| CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide | |
| CLASS II | 0.9 % Sodium Chloride Irrigation recalled by B Braun MedicalSodium Chloride For Irrigation | B Braun Medical | Sterility | 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 Water recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Water for Irrigation, Single-Dose recalled by Baxter HealthcareSterile Water | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Sterile Water For Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | Sterile Water for Injection, USP, mL Single-Dose Vials recalledSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | SC |
| Drug | CLASS II | Sterile Water for Injection recalled by Nephron ScSterile Water | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sterile Water for Injection recalled by Mckesson Medical-SurgicalSterile Water | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |