The Recall Desk
SevereFDA (Drugs)·D-0415-2025·Announced 2025-05-14

Testosterone Pellet 200 mg Recalled Due to Glass Particles

BSO LLC is recalling Testosterone Pellet 200 mg compounded drug vials nationwide due to the presence of glass particles found in pellet vials.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as Class II. The hazard—glass particles in an injectable compounded drug—presents a direct risk of harm (physical injury, infection) upon injection, and no illnesses have been reported yet. Class II with a serious potential hazard meets the Severe (score 4) threshold.

Plain-English summary

BSO LLC is recalling Testosterone Pellet 200 mg (with Cholesterol ≤4%), 1 Pellet for Subcutaneous Use, a compounded drug distributed nationwide. The recall was initiated because glass particles were found in pellet vials.

The affected product is Lot 20250205@6 with an expiration date of 1/30/2026, with an NDC of 70168-0122-01. Approximately 1,447 vials have been distributed. This product is intended for office use only under prescription and is not for resale.

Patients and healthcare providers should discontinue use of this product from the affected lot. Contact BSO LLC or a healthcare provider with any questions or concerns.

The recalled product

Product
TESTOSTERONE PELLET 200 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: 70168-0122-01
Manufacturer
BSO LLC
Hazard
  • glass-particles
  • foreign-object-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 (2)

  • Lot 20250205@6
  • exp 1/30/2026

Distribution

Distributed nationwide across the United States.