The Recall Desk
HighFDA (Drugs)·D-0125-2026·Announced 2025-11-05

Testosterone pellets recalled for potential metal particulate contamination

FarmaKeio Outsourcing is recalling Testosterone 62.5 MG pellets (Lot 3180) due to potential metal particulate matter from manufacturing deviations. Product was distributed nationwide.

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: FDA Class II recall with no reported illnesses or injuries. The hazard (metal particulate matter) is theoretical, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

FarmaKeio Outsourcing LLC is recalling Testosterone 62.5 MG sterile pellets for subcutaneous insertion (Lot 3180, expiration 2/17/2026) distributed nationwide in the USA and Antigua. A total of 829 pellets are affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that resulted in the potential presence of metal particulate matter in the product.

Patients who have received this product should contact their healthcare provider immediately. Do not continue use of the affected lot. Return the product to your pharmacy or healthcare provider.

The recalled product

Product
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
Manufacturer
FARMAKEIO OUTSOURCING LLC
Category
Drug — Injectable / Hormone
Hazard
  • metal-particulate
  • manufacturing-defect

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 3180
  • EXP 2/17/2026

Distribution

Distributed nationwide across the United States.

Related recalls

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