FDA recall D-0092-2026

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.

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2025-07-30

Report date

2025-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0092-2026