US Drug Recall Register

FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated

Hyland's Baby Nighttime Teething Tablets

Reason Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

Standard Homeopathic Company NDC 54973-3197-1 D-0864-2017
Class I · High risk Terminated

Hyland's Baby Teething Tablets

Reason Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

Standard Homeopathic Company NDC 54973-3127-3 D-0863-2017
Class I · High risk Terminated

LaBri's Body Health Atomic

Reason Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.

Envy Me D-0867-2017
Class I · High risk Ongoing

EpiPen Jr. 2-Pak

Reason Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Meridian Medical Technologies a Pfizer Company NDC 49502-500-02 D-0691-2017
Class I · High risk Ongoing

EpiPen 2-Pak

Reason Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

Meridian Medical Technologies a Pfizer Company NDC 49502-500-02 D-0690-2017
Class I · High risk Terminated

MACA gold tablets

Reason 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.

A&H Focal Inc. D-0571-2018
Class I · High risk Terminated

LIEN CHAN FOR SEVEN DAYS capsules

Reason 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.

A&H Focal Inc. D-0570-2018
Class I · High risk Terminated

DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets

Reason 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.

A&H Focal Inc. D-0569-2018
Class I · High risk Terminated

Power V8 Viagra tablets

Reason 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.

A&H Focal Inc. D-0568-2018
Class I · High risk Terminated

YANSHIJIAONANG capsules

Reason 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.

A&H Focal Inc. D-0567-2018
Class I · High risk Terminated

HU HU SHENG WEI capsules

Reason 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.

A&H Focal Inc. D-0566-2018
Class I · High risk Terminated

Zhonghua Niubian tablets

Reason 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.

A&H Focal Inc. D-0563-2018
Class I · High risk Terminated

ZHANSHENG WEIGE CHAOYUE XILISHI tablets

Reason 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.

A&H Focal Inc. D-0562-2018
Class I · High risk Terminated

Clalis capsules

Reason 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.

A&H Focal Inc. D-0560-2018
Class I · High risk Terminated

GOLD VIGRA capsules

Reason 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.

A&H Focal Inc. D-0559-2018
Class I · High risk Terminated

LANG YI HAO CHAONONGSUOPIAN tablets

Reason 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.

A&H Focal Inc. D-0558-2018
Class I · High risk Terminated

GERMANY NIUBIAN tablets

Reason 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.

A&H Focal Inc. D-0556-2018
Class I · High risk Terminated

GERMANY BLACK GOLD tablets

Reason 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.

A&H Focal Inc. D-0555-2018
Class I · High risk Terminated

Miraculous Evil Root capsules

Reason 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.

A&H Focal Inc. D-0554-2018
Class I · High risk Terminated

XtraHRD Natural Male Enhancement Capsules

Reason Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).

Organic Herbal Supply D-0646-2017
Class I · High risk Terminated

Ibuprofen Lysine Injection

Reason Presence of Particulate Matter

X-Gen Pharmaceuticals Inc. NDC 39822-1030-1 D-0637-2017
Class I · High risk Terminated

Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only

Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

SCA Pharmaceuticals NDC 70004-0918-40 D-0645-2017
Class I · High risk Terminated

Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total…

Reason Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.

SCA Pharmaceuticals NDC 70004-0925-44 D-0643-2017