Tirzepatide Injections Recalled for Lack of Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide Injections (10mg/mL, pre-filled syringes) distributed nationwide due to lack of assurance of sterility. Consumers should not use the affected product and contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Lack of sterility assurance in an injectable drug poses a significant risk of serious adverse health consequences including infection, and the recall is appropriately classified at the Severe level per the rubric.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado), is recalling Tirzepatide Injections, 10mg/mL, in pre-filled syringes due to a lack of assurance of sterility. The recall affects 24-syringe packages distributed nationwide.
The recalled lots are: H272962 (expiration 12/5/2025), S5045185 (expiration 5/20/2025), and H270625 (expiration 9/30/2025).
Consumers who have received this product should not use it and should contact their healthcare provider for guidance. Healthcare providers should contact Thrive Health Solutions or the FDA if they have questions about the recall.
The recalled product
- Product
- Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Category
- Drug — Injectable / Injection
- Affected units
- 24
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.
Part of a larger recall action
This product is one of 14 recalled by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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