Testosterone Pellet 200 mg Recalled for Glass Particulate Matter
BSO LLC is recalling Testosterone Pellet 200 mg compounded drug vials nationwide because glass particles were found in the pellets intended for subcutaneous injection.
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: This is an FDA Class II recall of a drug product with a serious hazard—glass particles in an injectable drug—that could cause significant injury. Although no illnesses or injuries are explicitly reported in the source text, the risk of harm from glass in a subcutaneously injected pellet is substantial and meets the Severe (Class II) threshold.
Plain-English summary
BSO LLC is recalling Testosterone Pellet 200 mg (Blunt) compounded drug vials due to the presence of glass particles in the pellet vials. This product is a compounded drug intended for subcutaneous use and is restricted to prescription or office use only.
The recall affects 1,964 vials distributed nationwide in the USA. The affected lots are Lot 20250129@1 (expiration 1/17/2026) and Lot 20250218@4 (expiration 1/25/2026). The product is manufactured by BSO LLC, located at 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01.
Patients and healthcare providers who have this product should stop using it immediately and consult their prescribing physician for guidance on appropriate treatment options.
The recalled product
- Product
- TESTOSTERONE PELLET 200 mg BLUNT, 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: 70168-0121-01
- Manufacturer
- BSO LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 1,964
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 (4)
- Lot 20250129@1
- exp 1/17/2026
- Lot 20250218@4
- exp 1/25/2026
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
Same manufacturer · BSO LLC
See all →- ModerateTestosterone Pellet 100 mg recalled due to glass particle contamination
FDA (Drugs) · 2025-05-14
- SevereTestosterone Pellet 200 mg Recalled Due to Glass Particles
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- HighTestosterone Pellet 200 mg Recalled for Glass Particulate Matter
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- SevereTestosterone Pellet 200 mg Recalled for Glass Particle Contamination
FDA (Drugs) · 2025-05-14
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