Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Naloxone Hydrochloride Injection
Reason Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class I · High risk Terminated
Allergan Taytulla Softgel Capsules
Reason Contraceptive Tablets Out of Sequence.
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.
Class I · High risk Terminated
POSEIDON Xtreme PLATINUM 4500
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.
Class I · High risk Terminated
Piperacillin and Tazobactam for Injection
Reason Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I · High risk Terminated
Piperacillin and Tazobactam for Injection
Reason Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class I · High risk Terminated
Piperacillin and Tazobactam for Injection
Reason Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class I · High risk Terminated
Ampicillin and Sulbactam for Injection
Reason 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.
Class I · High risk Terminated
Euphoric Premium Male Performance Enhancer capsules
Reason Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
Class I · High risk Terminated
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack
Reason 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.
Class I · High risk Terminated
All Alka-Seltzer Plus¿ packages with a full front panel instant…
Reason Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.