The Recall Desk
SevereFDA (Drugs)·D-0482-2025·Announced 2025-07-02

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Manufacturer
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Hazard
  • sterility-assurance
  • contamination-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.