Class IIReported 2025-11-05

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

Recalled by FARMAKEIO OUTSOURCING LLC

Reason for Recall

CGMP Deviations: Potential presence of metal particulate matter

Recall Number

D-0129-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-10-14

Reported

2025-11-05

Distribution

Nationwide in the USA and Antigua

Code Info

Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.