TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for R
Summary
The FDA issued a Class II for TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous U by BSO LLC. Reason: Presence of Particulate Matter: Glass particles were found in pellet vials..
Details
Source
Drug Recall
External ID
D-0413-2025
Action Date
2025-05-14
Status
Ongoing
Category
drug
Product Description
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 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: 70168-0125-01
Lot/Code Info: Lot 20250207@1, exp 1/31/2026; Lot 20250228@1, exp 1/31/2026
Quantity Affected: 1,974 vials
Reason for Recall
Presence of Particulate Matter: Glass particles were found in pellet vials.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-28
Company
Lakewood, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
BSO LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BSO LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BSO LLC have FDA actions?
BSO LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0413-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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