Testosterone 80 mg pellet packaged in amber vial
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
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.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
CGMP Deviations
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
cGMP Deviations; lack of quality assurance.
Presence of Particulate Matter
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