← FDA ENFORCEMENT
D-0517-2025Class III

Qualgen, LLC

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
SPEQ quality domain
Documentation & Change Control
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

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Data: U.S. FDA openFDA enforcement API. 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.