Tirzepatide Injections Recalled Due to Lack of Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide Injections due to lack of assurance of sterility. Lot H388348 was distributed nationwide in the United States.
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 drug recall involving lack of sterility assurance for an injectable medication. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not been reported, warranting a High (3) rating.
Plain-English summary
Thrive Health and Wellness, LLC, dba Thrive Health Solutions, is recalling Tirzepatide Injections, 30mg/mL in pre-filled syringes. The recall is due to lack of assurance of sterility for lot H388348, meaning the manufacturer cannot confirm that this lot meets the sterility specifications required for injectable medications.
Lot H388348 was distributed nationwide in the United States. The recalled product was supplied in cases containing four pre-filled syringes.
The recalled product
- Product
- Tirzepatide Injections, 30mg/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
- 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 (1)
- Lot: H388348
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27