Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

37 recalls, newest first

Class I · High risk

RISE UP RED EDITION Capsules

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Terminated Chemical / undeclared Positive Health D-0645-2022
Class I · High risk

Avaphinal Maximum Male Enhancement Sexual Pills

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Terminated Chemical / undeclared Walmart Stores D-0725-2022
Class I · High risk

RED MAMMOTH capsules

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Terminated Chemical / undeclared Celebrate Today D-0638-2022
Class I · High risk

The Red Pill

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Terminated Chemical / undeclared Your Favorite Shop D-0630-2022
Class I · High risk

MAC DADDY PURPLE Capsules

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

Terminated Chemical / undeclared ABC Sales 1 Inc D-0563-2022
Class I · High risk

MAC DADDY RED Capsules

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.

Terminated Chemical / undeclared ABC Sales 1 Inc D-0562-2022
Class I · High risk

MegMan Performance Booster

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Terminated Chemical / undeclared Junp Hydration LLC D-0557-2022
Class I · High risk

Hard Dawn

Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.

Terminated Chemical / undeclared Esupplementsales, LLC D-0561-2022

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