Testosterone Recall: FARMAKEIO OUTSOURCING 87.5mg Pellet Lot 3193
Announced 2025-11-05 · FDA
FDA is recalling FARMAKEIO OUTSOURCING LLC's Testosterone pellet due to CGMP deviations that may involve metal particulate matter. The recall covers 529 pellets from Lot 3193, Exp 2/17/2026, distributed nationwide in the United States and Antigua. Corrective action is not specified in the provided data.
| Brand | FARMAKEIO OUTSOURCING LLC |
|---|---|
| Product | Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01 |
| Reason | CGMP Deviations: Potential presence of metal particulate matter |
| Severity | moderate |
| Units affected | 36924 |
| Distribution | Nationwide in the USA and Antigua |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any remaining pellets from Lot 3193.
- Contact your prescribing clinician or pharmacy for guidance and potential disposal options.
- Return or discard the recalled product according to FDA instructions or your supplier's guidance, keeping the lot number handy (Lot 3193).
- Seek medical advice if you experience any symptoms or concerns.
How to identify the recalled item
| Lot / date codes | Lot 3193, Exp 2/17/2026 |
|---|---|
| Lot / date codes | Lot: 3148, 3154, 3155, Exp 2/5/2026; 3162, Exp 2/11/2026; 3167, Exp 2/12/2026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.