Testosterone 200 mg Pellet packaged in 1mL amber vials recall
FDA recall D-0517-2025 · initiated Jun 16, 2025
Qualgen, LLC recalled Testosterone 200 mg Pellet packaged in 1mL amber vials in Jun 2025 — an FDA Class III recall (D-0517-2025) because Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,832 amber vials
Details
- 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
- Recalling company
- Qualgen, LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States.
- Initiated
- Jun 16, 2025
- FDA report date
- Jul 23, 2025
Frequently asked
- Was Testosterone 200 mg Pellet packaged in 1mL amber vials recalled?
- Qualgen, LLC recalled Testosterone 200 mg Pellet packaged in 1mL amber vials in Jun 2025 — an FDA Class III recall (D-0517-2025) because Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Testosterone 200 mg Pellet packaged in 1mL amber vials recalled?
- Per the FDA enforcement record, the reason for recall D-0517-2025 was: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
- Is a recalled Testosterone 200 mg Pellet packaged in 1mL amber vials dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Testosterone 200 mg Pellet packaged in 1mL amber vials are affected?
- Distributed: Nationwide within the United States.. The recall covers these lots — Lot number: 1043, Exp. Date 2/10/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0517-2025.