PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: November 5, 2025 Initiated: October 14, 2025 #D-0129-2026

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

Details

Recalling Firm
FARMAKEIO OUTSOURCING LLC
Units Affected
14,329 pellets
Distribution
Nationwide in the USA and Antigua
Location
Southlake, TX

Frequently Asked Questions

What product was recalled?
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. Units affected: 14,329 pellets.
Why was this product recalled?
CGMP Deviations: Potential presence of metal particulate matter
Which agency issued this recall?
This recall was issued by the FDA Drug on November 5, 2025. Severity: Moderate. Recall number: D-0129-2026.