Recall
FDAHealthJuly 30, 2025

GenoGenix LLC — Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, 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
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lot code
GG062425-002

Additional details

Lot#: GG062425-002 within expiry.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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