← FDA ENFORCEMENT
D-0412-2025Class II

BSO LLC

Recalling firm
BSO LLC
Product type
Drug
Status
Ongoing
Report date
2025-05-14
Distribution
Nationwide in the USA
Firm state
CO
Product quantity
2,762 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter: Glass particles were found in pellet vials.

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIOlympus Corporation of the Americas2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.