Class I · High risk
Phenobarbital Tablets USP
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Class I drug recalls - the high-risk category
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Class I · High risk
LabidaMAX Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ZRECT for Women Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ENHANCEROL Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
TORNADO Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
RECTALIS Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
Xrect Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ZRECT Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
Cummor Natural Male Enhancement
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
Hyland's Baby Nighttime Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Class I · High risk
Hyland's Baby Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Class I · High risk
LaBri's Body Health Atomic
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Class I · High risk
EpiPen Jr. 2-Pak
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class I · High risk
EpiPen 2-Pak
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class I · High risk
MACA gold tablets
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
LIEN CHAN FOR SEVEN DAYS capsules
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
Power V8 Viagra tablets
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
YANSHIJIAONANG capsules
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
HU HU SHENG WEI capsules
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
Zhonghua Niubian tablets
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Class I · High risk
ZHANSHENG WEIGE CHAOYUE XILISHI tablets
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.