Tirzepatide and Cyanocobalamin Injectable Products Recalled for Sterility Concerns
Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin injectable products due to lack of assurance of sterility. Lot C03125A (242 syringes) distributed nationwide should not be used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves an injectable product with lack of assurance of sterility, which is a risk-of-harm condition. No illnesses or injuries are reported, so per the rubric this does not meet the threshold for Severe (score 4), but the fundamental safety risk of an unsterile injectable justifies a High (score 3) rating.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado), is recalling Tirzepatide/Cyanocobalamin Injectable 30mg/1mg/mL pre-filled syringes because the manufacturer cannot assure the product meets sterility requirements.
The recalled product is lot C03125A, consisting of 242 syringes, distributed nationwide. Tirzepatide/Cyanocobalamin is used for weight management and metabolic support.
Injectable products must meet strict sterility standards to prevent infection. A lack of assurance of sterility means the manufacturer cannot guarantee the product is free from bacterial and fungal contamination.
Patients who have used this product should contact their healthcare provider. Healthcare providers and patients should not use syringes from lot C03125A and should return them to Thrive Health Solutions.
The recalled product
- Product
- Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Manufacturer
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Category
- Drug — Injectable
- Hazard
- sterility-failure
- contamination-risk
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: C03125A
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27