Class III · Low risk
Oxycodone Hydrochloride Tablets
Out-of-specification impurity test result observed at 18-month long term stability time point.
FDA Drug Recalls
107 recalls · Class III, newest first
Class III · Low risk
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class III · Low risk
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree sample boxes
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx36 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx26 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx21 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx7 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Labeling: Missing Label
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg per 5 mL
Labeling: Missing Label
Class III · Low risk
Telmisartan and Hydrochlorothiazide Tablets
Superpotent; Hydrochlorothiazide
Class III · Low risk
Tydemy
Subpotent Drug
Class III · Low risk
Carvedilol Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Allergy Relief D Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
12 HR Allergy & Congestion Relief Fexofenadine HCl
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Relief Allergy Relief D
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Failed dissolution specifications
Class III · Low risk
Clonidine Transdermal System
Failed Impurities/Degradation Specifications
Class III · Low risk
Topiramate Tablets
Discoloration