FARMAKEIO OUTSOURCING LLC: Drug Recall

Recall #D-0128-2026 · 10/14/2025

Class II: Risk

Recall Details

Recall Number
D-0128-2026
Classification
Class II
Product Type
Drug
Recalling Firm
FARMAKEIO OUTSOURCING LLC
Status
Ongoing
Date Initiated
10/14/2025
Location
Southlake, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,829 pellets

Reason for Recall

CGMP Deviations: Potential presence of metal particulate matter

Product Description

Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01

Distribution Pattern

Nationwide in the USA and Antigua

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.