Tirzepatide Injections recalled over sterility concerns

Recall date

May 21, 2025

Source

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

Official notice title

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewo…

Recall number

D-0484-2025

FDA classification

Class II

Brand / firm

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Sold / distributed

USA 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 Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112