Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Quillivant XR
Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk Terminated
Quillivant XR
Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class III · Low risk Terminated
Quillivant XR
Reason Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Class II · Moderate risk Terminated
ATENOLOL Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk Terminated
Tiger King 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.
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.
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.
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.
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.
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.
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.
Class II · Moderate risk Terminated
MAX MAN 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.
Class II · Moderate risk Terminated
STREE OVERLORD 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.
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.
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.
Class II · Moderate risk Terminated
Ye Lang Shen 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.
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.