Testosterone Pellet 200 mg Recalled for Glass Particulate Matter
BSO LLC is recalling Testosterone Pellet 200 mg vials nationwide due to the presence of glass particles found in pellet vials. Patients should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a risk-of-harm hazard (glass particulate matter in an injectable drug). Although no reported illnesses or injuries are documented in the source text, glass particles in pellet vials pose a direct risk of injury to patients receiving subcutaneous injection, warranting a High severity classification.
Plain-English summary
BSO LLC is recalling Testosterone Pellet 200 mg BLUNT (with Cholesterol ≤2%), a compounded drug for subcutaneous use, due to the presence of particulate matter. Glass particles were found in pellet vials.
The recalled product is Lot 20250217@7 with an expiration date of 1/31/2026. A total of 355 vials have been distributed nationwide in the USA. This product is for office use only and not for resale.
Patients who have received this product should contact their healthcare provider immediately. Healthcare providers should review patient records and follow appropriate medical guidance regarding any necessary medical evaluation or additional treatment.
The recalled product
- Product
- TESTOSTERONE PELLET 200 mg BLUNT (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: 70168-0124-01
- Manufacturer
- BSO LLC
- Category
- Drug — Compounded Injectable
- Hazard
- glass-particulate
- contamination
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 20250217@7
- exp 1/31/2026
Distribution
Distributed nationwide across the United States.
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