FDA Recall D-0483-2025

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Englewood, CO

Class II Ongoing 358 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Lot / code: Lot #BH11235 exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH00048 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ;

Quantity: 826 syringes

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0483-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: USA Nationwide
Recall initiated: 2025-05-21
Classified by FDA Center: 2025-06-20
FDA published: 2025-07-02
Recalling firm: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Firm location: Englewood, CO

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls