Tirzepatide recalled over sterility concerns

Recall date

July 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

GenoGenix LLC recalls Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 20…

Recall number

D-0092-2026

FDA classification

Class II

Brand / firm

GenoGenix LLC

Sold / distributed

US Nationwide.

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.