# FDA recall D-0517-2025

> **Qualgen, LLC** · Class III · drug recall initiated 2025-06-16.

## Product

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

## Distribution

Nationwide within the United States.

## Key facts

- **Recall number:** D-0517-2025
- **Recalling firm:** Qualgen, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-16
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Edmond, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0517-2025

## Citation

> AI Analytics. FDA recall D-0517-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0517-2025. Source: US FDA. Licensed CC0.

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