FDA Drug recall D-0517-2025
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product
- FDA Drug
- Class III
- ongoing
- Published 2025-07-23
On 2025-07-23 the FDA classified a Class III recall of Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product by Qualgen, citing labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0517-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-06-16 |
| Published | 2025-07-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Qualgen |
| Distribution | US |
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
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Identifiers
| code_info | Lot number: 1043, Exp. Date 2/10/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0517-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.