FDAClass IIOctober 15, 2025

Bacteriostatic Water for Injection recall: Sterility Concern

Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled…

Why was Bacteriostatic Water for Injection recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots within expiry.

Product
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled…
Recalling firm
GenoGenix LLC
Distribution
US Nationwide.
Recall date
October 15, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls