The Recall Desk
ModerateFDA (Drugs)·D-0412-2025·Announced 2025-05-14

Testosterone Pellet 100 mg recalled due to glass particle contamination

BSO LLC is recalling Testosterone Pellet 100 mg (compounded, office use only) distributed nationwide due to glass particles found in pellet vials.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with a potential contamination hazard (glass particles). However, no illnesses, injuries, or hospitalizations are reported in the source text, and the contamination is a product-defect issue rather than a high-risk pathogen or allergen. Per the rubric, Class II without reported harm typically scores 2–3; the presence of a physical hazard (glass) without reports of actual injury supports a Moderate score.

Plain-English summary

BSO LLC is recalling Testosterone Pellet 100 mg (with Cholesterol ≤4%), a compounded subcutaneous drug product, distributed nationwide in the USA. Glass particles were found in pellet vials, posing a risk of injury or contamination if the product is used.

The affected product includes vials from Lot 20250102@6 (expiration 12/11/2025) and Lot 20250130@4 (expiration 1/22/2026). The product is labeled for office or RX use only and is not intended for resale. Patients or healthcare providers who have received this product should contact their physician or healthcare provider before using it.

This is a Class II recall issued by the FDA. For more information, consumers and healthcare providers should contact BSO LLC or the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls.

The recalled product

Product
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
Manufacturer
BSO LLC
Category
Drug — Compounded Hormone Therapy
Hazard
  • glass-particles
  • contamination

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 (4)

  • Lot 20250102@6
  • exp 12/11/2025
  • Lot 20250130@4
  • exp 1/22/2026

Distribution

Distributed nationwide across the United States.

Related recalls

Same category