D-0129-2026Class II

FARMAKEIO OUTSOURCING LLC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-11-05

Distribution

Nationwide in the USA and Antigua

Firm state

Product quantity

14,329 pellets

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

CGMP Deviations: Potential presence of metal particulate matter

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring

2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP 2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC

See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.