The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0413-2025·Announced 2025-05-14

Testosterone Pellet 200 mg Recalled for Glass Particle Contamination

BSO LLC is recalling compounded testosterone pellets nationwide because glass particles were found in vials. Affected lot numbers are 20250207@1 and 20250228@1 (expiration 1/31/2026).

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 confirmed physical hazard (glass particles) that could cause harm if injected. Class II recalls with a risk of serious injury or harm to patients warrant a score of 4 under the rubric.

Plain-English summary

BSO LLC is recalling compounded testosterone pellets (200 mg, NDC 70168-0125-01) distributed nationwide in the USA. The recall was initiated because glass particles were found in pellet vials.

The affected product is a compounded testosterone pellet for subcutaneous use, dispensed for office or RX use only. Lot numbers 20250207@1 and 20250228@1 are affected, both with expiration date 1/31/2026. Approximately 1,974 vials have been distributed.

Patients and healthcare providers who have received this product should stop use. Affected vials should be returned to BSO LLC (Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228) or to the dispensing healthcare provider. For more information, patients should contact their healthcare provider.

The recalled product

Product
TESTOSTERONE PELLET 200 mg (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: 70168-0125-01
Manufacturer
BSO LLC
Category
Drug — Compounded Testosterone
Hazard
Affected units
1,974

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 (3)

  • Lot 20250207@1
  • exp 1/31/2026
  • Lot 20250228@1

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 →

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