Class IIReported 2025-10-15

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.

Recalled by GenoGenix LLC

Reason for Recall

Lack of Assurance of Sterility

Recall Number

D-0092-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-07-30

Reported

2025-10-15

Distribution

US Nationwide.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.