Recalls / Class II
Class IID-0412-2025
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
- Affected lot / code info
- Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
Why it was recalled
Presence of Particulate Matter: Glass particles were found in pellet vials.
Recalling firm
- Firm
- BSO LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 12860 W Cedar Dr Ste 211, N/A, Lakewood, Colorado 80228-1971
Distribution
- Quantity
- 2,762 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-04-28
- FDA classified
- 2025-05-06
- Posted by FDA
- 2025-05-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0412-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.