Tirzepatide Injections Recalled Due to Sterility Assurance Issues
Thrive Health Solutions is recalling 826 syringes of Tirzepatide Injections nationwide due to lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm injectable medication product with FDA Class II classification due to lack of sterility assurance. No illnesses or injuries are reported in the source text, so the score does not exceed 3 per the rubric.
Plain-English summary
Thrive Health and Wellness, LLC, operating as Thrive Health Solutions in Colorado, is recalling Tirzepatide Injections, 20mg/mL supplied in pre-filled syringes. The recall affects 826 units distributed nationwide.
The recall is being issued due to lack of assurance of sterility. Tirzepatide is an injectable medication, and sterility is critical to patient safety. Products that do not meet sterility standards could potentially be contaminated and pose a health risk to patients.
Consumers and healthcare providers who have received or dispensed these injections should not use the affected units. Contact Thrive Health Solutions or your healthcare provider if you have received one of the recalled Tirzepatide Injections.
The recalled product
- Product
- Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Manufacturer
- Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- Category
- Drug — Injectable Medication
- Hazard
- lack-of-sterility
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 (17)
- Lot #BH11235 exp 5/5/2025
- BH11235
- exp 5/5/2025
- PRX11212024
- exp 5/20/2025
- BH272962
- BH00048
- PRX12825-2
- exp 7/27/2025
- PRO30625-2
- exp 9/2/2025
- PRX012825-2
- exp 9/27/2025
- AB11212024
- exp 11/21/2025
- BH66-1002
- exp 12/30/2025
Distribution
Distributed nationwide across the United States.
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