← FDA ENFORCEMENT
D-0517-2025Class III

Qualgen, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Qualgen, LLC
Product type
Drug
Status
Ongoing
Report date
2025-07-23
Distribution
Nationwide within the United States.
Firm state
OK
Product quantity
2,832 amber vials
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →