FDA recall D-0129-2026

FARMAKEIO OUTSOURCING LLC · Class II · drug

Product

Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

Distribution

Nationwide in the USA and Antigua

Key facts

Status: Ongoing
Initiation date: 2025-10-14
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Southlake, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0129-2026