Testosterone Pellet 200 mg Recalled Due to Glass Particles
BSO LLC is recalling Testosterone Pellet 200 mg compounded drug vials nationwide due to the presence of glass particles found in pellet vials.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class II. The hazard—glass particles in an injectable compounded drug—presents a direct risk of harm (physical injury, infection) upon injection, and no illnesses have been reported yet. Class II with a serious potential hazard meets the Severe (score 4) threshold.
Plain-English summary
BSO LLC is recalling Testosterone Pellet 200 mg (with Cholesterol ≤4%), 1 Pellet for Subcutaneous Use, a compounded drug distributed nationwide. The recall was initiated because glass particles were found in pellet vials.
The affected product is Lot 20250205@6 with an expiration date of 1/30/2026, with an NDC of 70168-0122-01. Approximately 1,447 vials have been distributed. This product is intended for office use only under prescription and is not for resale.
Patients and healthcare providers should discontinue use of this product from the affected lot. Contact BSO LLC or a healthcare provider with any questions or concerns.
The recalled product
- Product
- TESTOSTERONE PELLET 200 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: 70168-0122-01
- Manufacturer
- BSO LLC
- Category
- Drug — Compounded / Injectable
- Affected units
- 1,447
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 20250205@6
- exp 1/30/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by BSO LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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