FDA Drug recall D-0412-2025
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office…
- FDA Drug
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office… by Bso, citing presence of Particulate Matter: Glass particles were found in pellet vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0412-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-28 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bso |
| Distribution | US |
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
Reason
Presence of Particulate Matter: Glass particles were found in pellet vials.
Identifiers
| code_info | Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0412-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.