Tirzepatide injection syringes recalled due to lack of sterility assurance
Thrive Health Solutions is recalling Tirzepatide Injections (10mg/mL) in pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients should consult their healthcare provider.
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 an FDA Class II recall for an injectable medication due to lack of sterility assurance. While no illnesses or injuries have been reported, the potential for infection from non-sterile injections qualifies this as a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions, is recalling Tirzepatide Injections (10mg/mL) supplied in pre-filled syringes. The recalled product was distributed nationwide.
The reason for the recall is lack of assurance of sterility. For injectable medications, sterility is essential to prevent infection and other complications. Patients should not use the recalled product and should consult their healthcare provider for guidance.
The FDA classified this as a Class II recall. Patients who have received these injections should consult with their healthcare provider about this recall and any potential health concerns.
The recalled product
- Product
- Tirzepatide Injections, 10mg/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
- sterility-risk
- infection-risk
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 (8)
- Lot
- expiry: H272962
- exp 12/5/2025
- S5045185
- exp 5/20/2025
- H272962
- H270625
- exp 9/30/2025
Distribution
Distributed nationwide across the United States.
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