Class II · ModerateActive recall
Sterile Water
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byB. Braun Medical Inc.
| Brand name | STERILE WATER |
| Generic name | WATER |
| Active ingredient(s) | WATER |
| Distributed by / for | B BRAUN MEDICAL INC |
| NDC | 0264-7385-60 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | B BRAUN MEDICAL INC |
| Distribution | US Nationwide. |
| Quantity | 24,928 bags |
| Recall initiated | 2026-04-02 |
| Report date | 2026-04-29 |
| Recall completed | — |
| Recall number | D-0495-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Allentown PA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.