Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Farm...
FDA Recall #D-0129-2026 — Class II — October 14, 2025
Product Description
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
Recalling Firm
FARMAKEIO OUTSOURCING LLC — Southlake, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
14,329 pellets
Distribution
Nationwide in the USA and Antigua
Code Information
Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated