Qualgen, LLC recalls Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Ed…

Recall date

June 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0517-2025

FDA classification

Class III

Brand / firm

Qualgen, LLC

Sold / distributed

Nationwide within the United States.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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