Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,134 recalls, newest first

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.

Terminated Chemical / undeclared A&H Focal Inc. D-0569-2018
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.

Terminated Chemical / undeclared A&H Focal Inc. D-0568-2018
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.

Terminated Chemical / undeclared A&H Focal Inc. D-0567-2018
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.

Terminated Chemical / undeclared A&H Focal Inc. D-0566-2018
Class II · Moderate risk

MAX MAN 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.

Terminated Chemical / undeclared A&H Focal Inc. D-0565-2018
Class II · Moderate risk

STREE OVERLORD 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.

Terminated Chemical / undeclared A&H Focal Inc. D-0564-2018
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.

Terminated Chemical / undeclared A&H Focal Inc. D-0563-2018
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.

Terminated Chemical / undeclared A&H Focal Inc. D-0562-2018
Class II · Moderate risk

Ye Lang Shen 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.

Terminated Chemical / undeclared A&H Focal Inc. D-0561-2018
Class I · High risk

Clalis 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.

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

GOLD VIGRA 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.

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

LANG YI HAO CHAONONGSUOPIAN 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.

Terminated Chemical / undeclared A&H Focal Inc. D-0558-2018
Class II · Moderate risk

HARD TEN 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.

Terminated Chemical / undeclared A&H Focal Inc. D-0557-2018
Class I · High risk

GERMANY 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.

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

GERMANY BLACK 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.

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

Miraculous Evil Root 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.

Terminated Chemical / undeclared A&H Focal Inc. D-0554-2018
Class III · Low risk

Indian God Lotion Spray Bottle

Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Unapproved drug A&H Focal Inc. D-0553-2018
Class II · Moderate risk

Black Ant 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.

Terminated Chemical / undeclared A&H Focal Inc. D-0552-2018
Class III · Low risk

RIVASTIGMINE Tartrate Capsules

Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.

Terminated Cross-contamination Dr. Reddy's Laboratories, Inc. NDC 55111-352-60 D-0649-2017
Class II · Moderate risk

ATENOLOL Tablets

Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.

Terminated Particulate / foreign matter Zydus Pharmaceuticals USA Inc NDC 68382-023-01 D-0605-2017
Class II · Moderate risk

Desonide Ointment

Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream

Terminated Labeling / mix-up Fougera Pharmaceuticals Inc. NDC 0168-0309-60 D-0612-2017
Class III · Low risk

Penicillin V Potassium Tablets

Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg

Terminated Cross-contamination Citron Pharma Llc NDC 57237-041-99 D-0652-2017

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