Tirzepatide Injections Pre-filled Syringe Recalled for Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide Injections 20mg/mL pre-filled syringes due to lack of assurance of sterility. Approximately 826 syringes distributed nationwide are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. No illnesses or injuries have been reported, and the hazard remains theoretical; therefore, the recall does not meet the higher threshold of Class II with hospitalization reports. This qualifies as a Moderate severity recall.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) is recalling Tirzepatide Injections, 20mg/mL, pre-filled syringes. The recall affects approximately 826 syringes that were distributed nationwide. Multiple lot numbers are included in this recall, with expiration dates ranging from May 2025 through December 2025.
The product is being recalled due to lack of assurance of sterility. This is a Class II recall issued by the FDA.
Patients currently using the recalled syringes should contact their healthcare provider or pharmacist. The manufacturer and FDA have not reported any illnesses or adverse events associated with the use of these syringes to date. Consumers should not attempt to use remaining doses and should contact Thrive Health Solutions or their healthcare provider for instructions on replacement or alternative treatment options.
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
- Hazard
- lack-of-sterility-assurance
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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