US Drug Recall Register

FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1014-2018
Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1013-2018
Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1012-2018
Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1011-2018
Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1010-2018
Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1009-2018
Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1008-2018
Class I · High risk Terminated

Gaia Kratom

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

Gaia Ethnobotanical LLC D-1007-2018
Class I · High risk Terminated

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Gaia Kratom

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

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

Naloxone Hydrochloride Injection

Reason Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

Hospira INC, Lake Forest NDC 0409-1782-03 D-0906-2018
Class I · High risk Terminated

Allergan Taytulla Softgel Capsules

Reason Contraceptive Tablets Out of Sequence.

Allergan, PLC. NDC 0023-5862-28 D-0875-2018
Class I · High risk Terminated

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

Reason 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.

Shoreside Enterprises Inc. D-0880-2018