Testosterone 62 — Class II drug recall D-0125-2026
Ongoing recall by FARMAKEIO OUTSOURCING LLC, reported 2025-11-05, distributed nationwide. CGMP Deviations: Potential presence of metal particulate matter
| Recall number | D-0125-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FARMAKEIO OUTSOURCING LLC, Southlake, TX, United States |
| Recall initiated | 2025-10-14 |
| Classified | 2025-10-29 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 829 pellets |
| Reason classes | cgmp, specification failure |
| NDC | 73693-0383-01 |
| Lot numbers | 3180 |
| Expiration dates | 2026-02-17 |
Product
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
Reason for recall
CGMP Deviations: Potential presence of metal particulate matter
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-0125-2026. 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.