CJC-1295 Injectable Pre-filled Syringes Recalled for Sterility Assurance
Thrive Health Solutions is recalling CJC-1295 Injectable 6mg/15mg pre-filled syringes due to lack of assurance of sterility. The affected product was 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 recall is classified as FDA Class II by the agency. A sterility defect in an injectable drug product poses a risk of serious infection and meets the criteria for Severe classification as a Class II recall involving a risk-of-harm injectable product where the hazard (potential microbial contamination) is significant, though no illnesses have been explicitly reported in the source text.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado), is recalling CJC-1295 Injectable 6mg/15mg pre-filled syringes because the manufacturer cannot assure the product's sterility. The affected lots are Lot# H261968 (Exp 12/23/2025) and Lot# H261358 (Exp 5/13/2025), which were distributed nationwide in a quantity of 60 syringes.
Consumers who have received this product should not use it. Anyone with questions or concerns about their health should contact their healthcare provider.
The recalled product
- Product
- CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Category
- Drug — Injectable
- Hazard
- Affected units
- 60
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 (4)
- Lot#: H261968
- Exp 12/23/2025
- H261358
- Exp 5/13/2025
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 →- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- 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
Similar recalls
- SevereAssurance Infusion Recalls CJC-1295 and Ipamorelin Injections Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- HighInjectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- HighAssurance Infusion Recalls TRIMIX Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- HighTRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance
FDA (Drugs) · 2022-09-21
- SevereCJC-1295/Ipamorelin Injections Recalled Due to Sterility Concerns
FDA (Drugs) · 2021-11-17
- SevereFDA Recalls CJC-1295 Vials Due to Sterility Concerns
FDA (Drugs) · 2020-12-23