The Peptide Gazette

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13 October 2026 34 primary records on file thepeptidegazette.com

Recalls ยท 2 July 2025

Thrive Health Solutions recalls three compounded syringe presentations

Three Class II recalls initiated on the same day cover pre-filled syringes of semaglutide, of tirzepatide, and of a tirzepatide and cyanocobalamin combination.

Silver Spring, Maryland, 2 July 2025 — The Food and Drug Administration enforcement file records three ongoing Class II recalls initiated by Thrive Health and Wellness, LLC, trading as Thrive Health Solutions, of Englewood, Colorado, on 21 May 2025 and classified on 20 June 2025.

The three records cover 164 pre-filled syringes of compounded semaglutide, 216 of a compounded tirzepatide and cyanocobalamin combination, and 4 of compounded tirzepatide. All three are recorded as voluntary and firm-initiated, were notified by e-mail, were distributed nationwide, and give the reason as lack of assurance of sterility.

Source documents

  1. Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 Enforcement report, Class II · U.S. Food and Drug Administration · 2 July 2025
    Identifier
    Recall number D-0480-2025
    As the record states
    Lack of Assurance of Sterility
    Recalling firm
    Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
    Firm location
    Englewood, CO, United States
    Classification
    Class II
    Status on the record
    Ongoing
    Quantity
    164 syringes
    Distribution
    USA Nationwide
    Initiated
    2025-05-21
    Classified
    2025-06-20
  2. Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 Enforcement report, Class II · U.S. Food and Drug Administration · 2 July 2025
    Identifier
    Recall number D-0484-2025
    As the record states
    Lack of Assurance of Sterility
    Recalling firm
    Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
    Firm location
    Englewood, CO, United States
    Classification
    Class II
    Status on the record
    Ongoing
    Quantity
    4 syringes
    Distribution
    USA Nationwide
    Initiated
    2025-05-21
    Classified
    2025-06-20
  3. Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 Enforcement report, Class II · U.S. Food and Drug Administration · 2 July 2025
    Identifier
    Recall number D-0485-2025
    As the record states
    Lack of Assurance of Sterility
    Recalling firm
    Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
    Firm location
    Englewood, CO, United States
    Classification
    Class II
    Status on the record
    Ongoing
    Quantity
    216 syringes
    Distribution
    USA Nationwide
    Initiated
    2025-05-21
    Classified
    2025-06-20