Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot number: 1043, Exp. Date 2/10/2026
Where it was sold
Nationwide within the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0517-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 16, 2025
- FDA report date
- Jul 23, 2025
- Quantity
- 2,832 amber vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen, LLC
Original FDA data
Every field from FDA enforcement report D-0517-2025, exactly as published.
Show all FDA fields
- City
- Edmond
- State
- OK
- Status
- Ongoing
- Country
- United States
- Event ID
- 97086
- Address
- 14844 Bristol Park Blvd
- Code information
- Lot number: 1043, Exp. Date 2/10/2026
- Postal code
- 73013-1891
- Report date
- Jul 23, 2025
- Product type
- Drugs
- Recall number
- D-0517-2025
- Classification
- Class III
- Recalling firm
- Qualgen, LLC
- Product quantity
- 2,832 amber vials
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States.
- Recall initiation date
- Jun 16, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2025