FDA Drug Recalls

Recalls / Class II

Class IID-0482-2025

Product

Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Affected lot / code info
Lot, expiry: H272962, exp 12/5/2025; S5045185, exp 5/20/2025; H272962, exp 12/5/2025; H270625, exp 9/30/2025

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
88 Inverness Cir E Unit A204, Englewood, Colorado 80112-5521

Distribution

Quantity
24 syringes
Distribution pattern
USA Nationwide

Timeline

Recall initiated
2025-05-21
FDA classified
2025-06-20
Posted by FDA
2025-07-02
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0482-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.