Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent drug
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Guaifenesin Dextromethorphan Syrup
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Ongoing
Compliance Dishwashing Liquid & Antibacterial Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Genuine Joe Antibacterial Lotion Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
ROYALAB Germ Away Antibacterial Hand Soap
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Array Liquid Antiseptic Handwash
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
boardwalk ANTIBACTERIAL HANDSOAP REFILL
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
MAXIM Assure Antibacterial
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Terminated
Bevacizumab
Reason Lack of Sterility Assurance
Class II · Moderate risk Ongoing
Trinity Gold Nutrition
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class III · Low risk Terminated
Hydralazine HCl Tablets
Reason Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class I · High risk Ongoing
ZapMax Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk Ongoing
ZoomMax Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk Ongoing
PeakMax Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk Ongoing
VitalityXtra Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.