Recalls / Class III

Class IIID-0517-2025

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

Affected lot / code info

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

Why it was recalled

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

Recalling firm

Firm

Qualgen, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

14844 Bristol Park Blvd, N/A, Edmond, Oklahoma 73013-1891

Distribution

Quantity

2,832 amber vials

Distribution pattern

Nationwide within the United States.

Timeline

Recall initiated

2025-06-16

FDA classified

2025-07-14

Posted by FDA

2025-07-23

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0517-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.