FDA Recall D-0413-2025

BSO LLC · Lakewood, CO

Class II Ongoing 381 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: Lot 20250207@1, exp 1/31/2026; Lot 20250228@1, exp 1/31/2026

Quantity: 1,974 vials

Reason for recall

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

Recall record

Recall number: D-0413-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-04-28
Classified by FDA Center: 2025-05-06
FDA published: 2025-05-14
Recalling firm: BSO LLC
Firm location: Lakewood, CO

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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