CLASS II ONGOING Drug recall · Reported 14 May 2025 · FDA Enforcement Report
Testosterone Pellet 100 mg (with Cholesterol </=4%) recalled by BSO
BSO is recalling Testosterone Pellet 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This, distributed nationwide in the US. The recall was initiated on 28 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0412-2025
- FDA event ID
- 96792
- Recalling firm
- BSO, Lakewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Apr 2025
- FDA classified
- 6 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Hormones & Birth Control
Timeline
| 28 Apr 2025 | Recall initiated by company | |
| 6 May 2025 | Classified by FDA | +8 days |
| 14 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Glass particles were found in pellet vials.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Testosterone Pellet 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This recalled?
Yes. BSO recalled Testosterone Pellet 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This on 28 Apr 2025. The recall is Class II and its status is Ongoing. Recall number D-0412-2025.
Why was it recalled?
Presence of Particulate Matter: Glass particles were found in pellet vials.
Which lots are affected?
Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BSO
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Pellet 200 mg (with Cholesterol </=2%) recalled by BSO | BSO | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Pellet 200 mg Blunt (with Cholesterol </=2%) recalled | BSO | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Pellet 200 mg (with Cholesterol </=4%) recalled by BSO | BSO | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Pellet 200 mg Blunt, 1 Pellet recalled by BSO | BSO | Particulate Matter | Nationwide |