TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%) recall
FDA recall D-0412-2025 · initiated Apr 28, 2025
BSO LLC recalled TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%) in Apr 2025 — an FDA Class II recall (D-0412-2025) because Presence of Particulate Matter: Glass particles were found in pellet vials.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Glass particles were found in pellet vials.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,762 vials
Details
- Product
- 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
- Recalling company
- BSO LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 28, 2025
- FDA report date
- May 14, 2025
Frequently asked
- Was TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%) recalled?
- BSO LLC recalled TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%) in Apr 2025 — an FDA Class II recall (D-0412-2025) because Presence of Particulate Matter: Glass particles were found in pellet vials. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%) recalled?
- Per the FDA enforcement record, the reason for recall D-0412-2025 was: Presence of Particulate Matter: Glass particles were found in pellet vials.
- Is a recalled TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0412-2025.