Recall
FDAHealthJuly 30, 2025

GenoGenix LLC — Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

⚠️ Lack of Assurance of Sterility

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 30, 2025

US Nationwide.

What's affected?

Product
Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lot code
within

Additional details

All lots within expiry.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 30.

View original FDA notice →

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