FDA Recall D-0517-2025
Qualgen, LLC · Edmond, OK
Class III Ongoing 332 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Recall record
- Recall number
D-0517-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States.
- Recall initiated
- 2025-06-16
- Classified by FDA Center
- 2025-07-14
- FDA published
- 2025-07-23
- Recalling firm
- Qualgen, LLC
- Firm location
- Edmond, OK
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.