RECALL DATABASE

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.

BrandFARMAKEIO OUTSOURCING LLC
ProductTestosterone 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
ReasonCGMP Deviations: Potential presence of metal particulate matter
Severitymoderate
Units affected36924
DistributionNationwide in the USA and Antigua
AgencyFDA
Recall / campaign no.Lot 3193, Exp 2/17/2026

WHAT YOU SHOULD DO

  1. Do not use any remaining pellets from Lot 3193.
  2. Contact your prescribing clinician or pharmacy for guidance and potential disposal options.
  3. Return or discard the recalled product according to FDA instructions or your supplier's guidance, keeping the lot number handy (Lot 3193).
  4. Seek medical advice if you experience any symptoms or concerns.

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.