FDA recall D-0517-2025

Qualgen, LLC · Class III · drug

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

Status: Ongoing
Initiation date: 2025-06-16
Report date: 2025-07-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Edmond, OK, United States

Primary source

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