Drug FDA Class II Ongoing Foreign material
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
BSO LLC Published May 14, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact BSO LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Presence of Particulate Matter: Glass particles were found in pellet vials.
Hazards
Glass Particulate · primary
Affected products (1)
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
2,762 vials
Lot codes: 20250102, 20250130
Code info: Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
Affected areas
Nationwide
Timeline
- InitiatedApr 28, 2025
- PublishedMay 14, 2025
- Recall number
- D-0412-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.