Class II · ModerateActive recall
Tirzepatide Injections
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot: H388348
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Lack of Assurance of Sterility
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) |
Show the full FDA record
| Full product label | Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 |
| Recalling firm | Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) |
| Distribution | USA Nationwide |
| Quantity | 4 syringes |
| Recall initiated | 2025-05-21 |
| Report date | 2025-07-02 |
| Recall completed | — |
| Recall number | D-0484-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Englewood CO United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.