Class II · Moderate risk
Carbo-O-Philic 40 Cream 40%
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Meclizine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Meclizine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class III · Low risk
Duloxetine Delayed-release Capsules
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class III · Low risk
Ranitidine Syrup
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Class III · Low risk
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
HPMC Visoelastic Topical
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
HPMC Visoelastic
Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class II · Moderate risk
Salicylic Acid Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Quad Mix Strong Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Mix LOW ED Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcin40/Lido5 mg/mL Sus
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcin 40mg/mL Susp
Lack of Assurance of Sterility
Class II · Moderate risk
Tacrolimus 0.03% Opth Oint
Lack of Assurance of Sterility
Class II · Moderate risk
Super B Complex w/Cyano Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Super B Complex 3X Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Lipodissolve 100/50mg Inj Sol
Lack of Assurance of Sterility
Class II · Moderate risk
HCG 1000unit/10mL MTU vial
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Hydroxide 10% Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Chloride 0.9% Inj
Lack of Assurance of Sterility
Class II · Moderate risk
17-Hydroxyprogesterone 250mg/mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 1mg Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Wilson's Nasal Irrigation Solution
Lack of Assurance of Sterility
Class II · Moderate risk
VitB12/VitC/VitB3/VitB9 Inj
Lack of Assurance of Sterility