Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

18,003 recalls, newest first

Class III · Low risk

Adalat CC (nifedipine)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Terminated Cross-contamination Alvogen, Inc D-0635-2017
Class III · Low risk

Adalat CC (nifedipine)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Terminated Cross-contamination Alvogen, Inc D-0634-2017
Class III · Low risk

Adalat CC (nifedipine)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Terminated Cross-contamination Alvogen, Inc D-0633-2017
Class III · Low risk

Adalat CC (nifedipine)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Terminated Cross-contamination Alvogen, Inc D-0632-2017
Class III · Low risk

Adalat CC (nifedipine)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Terminated Cross-contamination Alvogen, Inc NDC 50419-702-05 D-0629-2017
Class III · Low risk

Adalat CC (nifedipine)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Terminated Cross-contamination Alvogen, Inc NDC 50419-701-05 D-0628-2017
Class III · Low risk

Quillivant XR

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Terminated Dissolution failure Pfizer Inc NDC 24478-190-30 D-0609-2017
Class III · Low risk

Quillivant XR

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Terminated Dissolution failure Pfizer Inc NDC 24478-205-25 D-0608-2017
Class III · Low risk

Quillivant XR

Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.

Terminated Dissolution failure Pfizer Inc NDC 24478-190-10 D-0607-2017
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 Legacy Pharmaceutical Packaging LLC NDC 68645-493-54 D-0606-2017
Class II · Moderate risk

Tiger King 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-0572-2018
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.

Terminated Chemical / undeclared A&H Focal Inc. D-0571-2018
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.

Terminated Chemical / undeclared A&H Focal Inc. D-0570-2018
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

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