FDA Drugs recall ·

TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%)… recall

Recall number
D-0412-2025
Date
(initiated April 28, 2025)
Company / brand
Bso LLC
12860 W Cedar Dr Ste 211, Lakewood, CO, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
2,762 vials
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

Nationwide in the USA

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0412-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.