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Drug FDA Class II Ongoing Contamination / non-sterility

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

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) Published Jul 2, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

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

826 syringes

Lot codes: BH11235
Code info: 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 ;

Affected areas

Nationwide

Timeline

  1. Initiated
    May 21, 2025
  2. Published
    Jul 2, 2025
Recall number
D-0483-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.