Testosterone Regular Release 200 MG recall
FDA recall D-0129-2026 · initiated Oct 14, 2025
FARMAKEIO OUTSOURCING LLC recalled Testosterone Regular Release 200 MG in Oct 2025 — an FDA Class II recall (D-0129-2026) because CGMP Deviations: Potential presence of metal particulate matter.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Potential presence of metal particulate matter
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: 14,329 pellets
Details
- Product
- Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
- Recalling company
- FARMAKEIO OUTSOURCING LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Antigua
- Initiated
- Oct 14, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was Testosterone Regular Release 200 MG recalled?
- FARMAKEIO OUTSOURCING LLC recalled Testosterone Regular Release 200 MG in Oct 2025 — an FDA Class II recall (D-0129-2026) because CGMP Deviations: Potential presence of metal particulate matter. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Testosterone Regular Release 200 MG recalled?
- Per the FDA enforcement record, the reason for recall D-0129-2026 was: CGMP Deviations: Potential presence of metal particulate matter
- Is a recalled Testosterone Regular Release 200 MG 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 Regular Release 200 MG are affected?
- Distributed: Nationwide in the USA and Antigua. The recall covers these lots — Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.. 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-0129-2026.