Testosterone Regular Release 200 MG
CGMP Deviations: Potential presence of metal particulate matter
Yes — there is an active recall. 69 ongoing FDA recalls mention Testosterone (406 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Testosterone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Marketed Without an Approved NDA/ANDA
Lack of Assurance of Sterility
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Presence of foreign substance: Presence of Benzene.
Presence of foreign substance: Presence of Benzene.
Superpotent Drug
OOS for viscosity
Lack of Assurance of Sterility
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Superpotent Drug: Out of specification assay result was obtained during stability testing.
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