Drug recall
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol…
FDA recall event 97086 · Class III · Qualgen, LLC
Key facts
| Event ID | 97086 |
|---|---|
| Recall numbers | D-0517-2025 |
| Recalling firm | Qualgen, LLC |
| Product type | Drugs |
| Products | 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 |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. |
| Initiation date | Jun 16, 2025 |
| Report date | Jul 23, 2025 |
| City | Edmond |
| State | OK |
| Country | United States |
| FEI number | 3011286349 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: