FDA Drugs recall ·
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe… recall
- Recall number
- D-0485-2025
- Date
- (initiated May 21, 2025)
- Company / brand
- Thrive Health Solutions (Colorado)
88 Inverness Cir E Unit A204, Englewood, CO, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 216 syringes
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: C03065F
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0485-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.