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.
FDA Drug Recalls
2,661 recalls, newest first
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.
Class II · Moderate risk Ongoing
Xelstrym
Reason Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class II · Moderate risk Ongoing
Regadenoson Injection
Reason Labeling: Missing Label
Class III · Low risk Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only…
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
Dapsone Gel 7.5%
Reason Crystallization
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg
Reason Failed Impurities/Degradation Specification
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg
Reason Failed Impurities/Degradation Specification
Class II · Moderate risk Ongoing
Sunitinib Malate Capsules
Reason Labeling: Label Mix-Up
Class II · Moderate risk Ongoing
Sunitinib Malate Capsules
Reason Labeling: Label Mix-Up
Class II · Moderate risk Ongoing
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution
Reason Subpotent Drug
Class II · Moderate risk Ongoing
OneLAX Docusate Sodium Liquid
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.