This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients in FDA approved products for the treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in Adam’s Secret Extra Strength products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

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Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment. As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements. This marks the first time the FDA has issued a countrywide import alert for any category of drug product.

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When the first FDA alerts warning of methanol-contaminated hand sanitizers brands emerged, we reported them through our FDA alert system. Within weeks however, this trickle of hand sanitizer recalls turned into a flood. Learn more here.

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