Where's it on?
FDA · Drugs ·

Sterile Water for Injection USP, 3000 mL bags recall

B BRAUN MEDICAL INC recalled Sterile Water for Injection USP, 3000 mL bags on April 29, 2026 because of lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. It was sold nationwide.

Why it was recalled

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

What's recalled

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.

Quantity: 24,928 bags

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
B BRAUN MEDICAL INC, Allentown, PA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide.
Status
Ongoing
Recall number
D-0495-2026
Source
U.S. Food and Drug Administration

More drugs recalls

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCClear Eyes Redness Relief
· Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCLubricant Eye Drops-Cameron Pharmaceuticals
· Sterling Pharmaceutical Services LLCReliable -1 Laboratories
· Sterling Pharmaceutical Services LLC