Class II · Moderate risk
Array Liquid Antiseptic Handwash
cGMP Deviations: Out of specification results for micro in hand soap products.
Ongoing drug recalls - open right now
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
Class II · Moderate risk
boardwalk ANTIBACTERIAL HANDSOAP REFILL
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
MAXIM Assure Antibacterial
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Trinity Gold Nutrition
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class I · High risk
ZapMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
ZoomMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
PeakMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
VitalityXtra Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Xelstrym (dextroamphetamine)
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Class II · Moderate risk
Regadenoson Injection
Labeling: Missing Label
Class III · Low risk
IBU (ibuprofen)
Failed Tablet/Capsule Specifications
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
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
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 30 mg
Failed Impurities/Degradation Specification
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 15 mg
Failed Impurities/Degradation Specification
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up