Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 1484...
FDA Recall #D-0517-2025 — Class III — June 16, 2025
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Recalling Firm
Qualgen, LLC — Edmond, OK
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
2,832 amber vials
Distribution
Nationwide within the United States.
Code Information
Lot number: 1043, Exp. Date 2/10/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated