Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Tirzepatide Injections
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Drug: Tirzepatide
- Recalling firm
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0484-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Tirzepatide recalls
See all
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Other recalls by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
All 2025 recalls
Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
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