Testosterone 200 mg Pellet packaged in 1mL amber vials — Class III drug recall D-0517-2025
Ongoing recall by Qualgen, LLC, reported 2025-07-23, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the
| Recall number | D-0517-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualgen, LLC, Edmond, OK, United States |
| Recall initiated | 2025-06-16 |
| Classified | 2025-07-14 |
| Reported by FDA | 2025-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 2,832 amber |
| Reason classes | labeling |
| NDC | 69761-0202-01 |
| Lot numbers | 1043 |
| Expiration dates | 2026-02-10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0517-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.