# FDA recall D-0484-2025

> **Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)** · Class II · drug recall initiated 2025-05-21.

## Product

Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

## Reason for recall

Lack of Assurance of Sterility

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0484-2025
- **Recalling firm:** Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-21
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Englewood, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0484-2025

## Citation

> AI Analytics. FDA recall D-0484-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0484-2025. Source: US FDA. Licensed CC0.

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