Recall
FDAHealthOctober 14, 2025

FARMAKEIO OUTSOURCING LLC — 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 736

⚠️ CGMP Deviations: Potential presence of metal particulate matter

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 14, 2025

Nationwide in the USA and Antigua

What's affected?

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

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 14,329 pellets.

View original FDA notice →

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