Class I · High risk Terminated
Super Samurai-X
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Ginseng Power-X
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk Terminated
Ninja-X
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk Terminated
Tiger-X
Reason Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk Terminated
BLACK GOLD X ADVANCED capsules
Reason Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk Terminated
BLACK LABEL X capsules
Reason Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Class I · High risk Ongoing
Human Chorionic Gonadotropin
Reason Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Class I · High risk Terminated
PHENYLephrine 1 mg/10 mL
Reason Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Class I · High risk Terminated
Cap-Biotin 100 Mg
Reason Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class I · High risk Terminated
5% Dextrose Injection USP
Reason Non-Sterility: fungal contamination due to leaking containers.
Class I · High risk Ongoing
Magnesium Sulfate Inj.
Reason Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Class I · High risk Ongoing
8.4% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I · High risk Terminated
Amikacin Sulfate injection USP
Reason Presence of Particulate Matter: particulate matter identified as glass in one vial.
Class I · High risk Terminated
Morphine Sulfate 0.5 mg/mL
Reason Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Class I · High risk Terminated
CLINIMIX E 5/15 sulfite-free
Reason Presence of Particulate Matter: identified as dried skin.
Class I · High risk Terminated
Metronidazole Injection USP
Reason Presence of Particulate Matter: identified as a cloth fiber.
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter: identified as cardboard.
Class I · High risk Terminated
Licorice Coughing Liquid
Reason Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
Class I · High risk Terminated
Zhen Gong Fu
Reason Marketed Without An Approved NDA/ANDA
Class I · High risk Terminated
Super Hard
Reason Marketed Without An Approved NDA/ANDA
Class I · High risk Terminated
Samurai-X
Reason Marketed Without An Approved NDA/ANDA
Class I · High risk Terminated
Tiger King
Reason Marketed Without An Approved NDA/ANDA
Class I · High risk Terminated
Night Man
Reason Marketed Without An Approved NDA/ANDA
Class I · High risk Terminated
Mojo Risen
Reason Marketed Without An Approved NDA/ANDA
Class I · High risk Terminated
Man King
Reason Marketed Without An Approved NDA/ANDA