Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, ...
FDA Recall #D-0092-2026 — Class II — July 30, 2025
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
GenoGenix LLC — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
US Nationwide.
Code Information
Lots GG012925-005, GG021125-003, within expiry.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated