FDA Drugs recall ·

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only… recall

Recall number
D-0517-2025
Date
(initiated June 16, 2025)
Company / brand
Qualgen, LLC
14844 Bristol Park Blvd, Edmond, OK, United States
Category
Drugs › Class III
Classification
Class III
Status
Ongoing
Units affected
2,832 amber vials
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot number: 1043, Exp. Date 2/10/2026

Distribution

Nationwide within the United States.

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (drugs), recall D-0517-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.