Recall
FDAHealthJuly 30, 2025

GenoGenix LLC — Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Ex

⚠️ 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
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
Lot code
GG012925-005

Additional details

Lots GG012925-005, GG021125-003, within expiry.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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