Tirzepatide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin Injectable 15mg/1mg/mL pre-filled syringes (Lot C03065F) due to lack of assurance of sterility. The product was distributed nationwide in the USA.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II drug recall involving loss of sterility assurance in an injectable medication. Sterility failures in injectables pose risk of serious infection and other adverse health consequences; the product distribution is nationwide, and the agency's own classification as Class II with this hazard warrants a Severe rating.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions, is recalling Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe product (Lot C03065F) distributed nationwide in the USA. The recall involves 216 syringes manufactured by the Colorado-based firm.
The product is being recalled due to lack of assurance of sterility. Injectable medications require confirmed sterility to prevent serious infection and other adverse health effects.
Patients who have received this product should contact their healthcare provider immediately to discuss potential risks and next steps. Healthcare providers and patients should not use this product. The product should be returned or disposed of according to local pharmaceutical waste disposal guidelines.
The recalled product
- Product
- Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Affected units
- 216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: C03065F
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
See all →- SevereLX Bioboost Plus Pre-filled Syringe Recalled for Sterility Assurance
FDA (Drugs) · 2025-07-02
- SevereLL Bioboost Injectable pre-filled syringes recalled for lack of sterility assurance
FDA (Drugs) · 2025-07-02
- ModerateTirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance
FDA (Drugs) · 2025-07-02
- SevereTirzepatide Injections recalled due to lack of sterility assurance
FDA (Drugs) · 2025-07-02
- SevereSemaglutide/Cyanocobalamin Injectable Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2025-07-02
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24