The Recall Desk
HighFDA (Drugs)·D-0128-2026·Announced 2025-11-05

Testosterone 50 mg pellets recalled over potential metal particulate matter

FarmaKeio Outsourcing is recalling 4,829 sterile Testosterone Regular Release 50 mg pellets from one lot over the potential presence of metal particulate matter.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: metal particulate in a product inserted under the skin is a hazard, and no injuries are reported.

Plain-English summary

Testosterone Regular Release 50 MG, one sterile pellet for subcutaneous insertion, compounded by FarmaKeio Outsourcing of Southlake, Texas, is being recalled for CGMP deviations: the potential presence of metal particulate matter.

The recall covers 4,829 pellets from lot 3178, expiring 7 February 2026, carrying NDC 73693-0401-01. The product was distributed nationwide in the United States and in Antigua. The FDA has classified the recall as Class II.

The pellet is inserted under the skin, so foreign particulate matter would be introduced into the body. The enforcement record describes the potential contamination and reports no injuries.

Providers and patients holding lot 3178 should stop using it and contact the firm or their prescriber.

The recalled product

Product
Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
Manufacturer
FARMAKEIO OUTSOURCING LLC
Category
Drug — Hormone implant
Hazard
Affected units
4,829

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 3178
  • Exp 02/7/2026

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by FARMAKEIO OUTSOURCING LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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Same manufacturer · FARMAKEIO OUTSOURCING LLC

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Same hazard · particulate matter

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