Why it was recalled
Lack of Assurance of Sterility
Product description
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lot numbers, UPCs & expiration codes
Lot: H388348
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0484-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 21, 2025
- FDA report date
- Jul 2, 2025
- Quantity
- 4 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Original FDA data
Every field from FDA enforcement report D-0484-2025, exactly as published.
Show all FDA fields
- City
- Englewood
- State
- CO
- Status
- Ongoing
- Country
- United States
- Event ID
- 96742
- Address
- 88 Inverness Cir E Unit A204
- Code information
- Lot: H388348
- Postal code
- 80112-5521
- Report date
- Jul 2, 2025
- Product type
- Drugs
- Recall number
- D-0484-2025
- Classification
- Class II
- Recalling firm
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Product quantity
- 4 syringes
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Distribution pattern
- USA Nationwide
- Recall initiation date
- May 21, 2025
- Initial firm notification
- Center classification date
- Jun 20, 2025