Testosterone 62 recalled over manufacturing violations
- Recall date
- October 14, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- FARMAKEIO OUTSOURCING LLC recalls Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave,…
- Recall number
- D-0125-2026
- FDA classification
- Class II
- Brand / firm
- FARMAKEIO OUTSOURCING LLC
- Sold / distributed
- Nationwide in the USA and Antigua
Why it was recalled
CGMP Deviations: Potential presence of metal particulate matter
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
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