Tirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of an injectable drug product with a sterility assurance failure. Lack of sterile assurance in injectable medications represents a serious risk of harm including infection, and the product is subject to regulatory classification as Class II, meeting the criteria for Severe.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions, is recalling Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL) pre-filled syringes, Lot C03125A, due to lack of assurance of sterility. A total of 242 syringes from this lot were distributed nationwide.
The lack of assured sterility means the product may not meet required safety and purity standards for injectable medications. Consumers who have received this product should contact their healthcare provider immediately for guidance. Healthcare providers and patients should not use or administer product from this lot.
Consumers with questions about this recall or who believe they have been affected should contact Thrive Health Solutions at 88 Inverness Circle East, Suite A-204, Englewood, Colorado 80112.
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
- Category
- Drug — Injectable / Compounded
- Affected units
- 242
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.
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 failure
See all →- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
- HighOmnicell IVX Station Reconstitution Transfer Sets Recall
FDA (Devices) · 2025-04-16
- HighCompounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance
FDA (Drugs) · 2025-04-02
- HighInjectable Phenylephrine Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03
- HighHYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03
Similar recalls
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- HighSemaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-09-21
- HighSemaglutide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Failure
FDA (Drugs) · 2022-09-21
- HighCyanocobalamin Injection Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20