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

231 recalls · Class I, newest first

Class I · High risk

The Rock

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

Ongoing Chemical / undeclared Noah's Wholesale LLC D-0158-2024
Class I · High risk

SANDIMMUNE Oral Solution

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Ongoing Failed specification Novartis Pharmaceuticals Corp. NDC 0078-0110-22 D-1174-2023
Class I · High risk

Vegetal Vigra

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

Ongoing Chemical / undeclared Apg Seven, INC D-1150-2023
Class I · High risk

DYNAMITE SUPER capsule

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Ongoing Chemical / undeclared Gadget Island, Inc D-0573-2023
Class I · High risk

NUX Male Enhancement capsule

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Ongoing Chemical / undeclared Gadget Island, Inc D-0572-2023
Class I · High risk

Pro Power Knight Plus capsule

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Ongoing Chemical / undeclared Gadget Island, Inc D-0571-2023
Class I · High risk

Atovaquone Oral Suspension USP

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

Ongoing Microbial contamination Camber Pharmaceuticals Inc. NDC 31722-629-21 D-0567-2023
Class I · High risk

Artificial Tears

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

Ongoing Sterility / contamination Global Pharma Healthcare Private Limited NDC 79503-0101-15 D-0919-2023

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