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

1,463 recalls · Class I, newest first

Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1006-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1005-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1004-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1003-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1002-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1001-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-1000-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-0999-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-0998-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-0997-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-0996-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-0995-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-0994-2018
Class I · High risk

Gaia Kratom

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Terminated Microbial contamination Gaia Ethnobotanical LLC D-0993-2018
Class I · High risk

7K capsules packaged in single packs sold in 24-count boxes

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Terminated Chemical / undeclared Shoreside Enterprises Inc. D-0880-2018
Class I · High risk

POSEIDON Xtreme PLATINUM 4500

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Terminated Chemical / undeclared Shoreside Enterprises Inc. D-0879-2018
Class I · High risk

Ampicillin and Sulbactam for Injection

Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.

Terminated Particulate / foreign matter AuroMedics Pharma LLC NDC 55150-117-20 D-0866-2018
Class I · High risk

Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Terminated Chemical / undeclared AMA Wholesale D-0821-2018

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