Class II · Moderate risk
Moisturizing Lubricant Eye Drops
Failed Stability Specification: out of specification results for Sodium Perborate
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations
Class I · High risk
Levoleucovorin Injection
Presence of Particulate Matter: particulate matter identified as copper salts
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II · Moderate risk
Divalproex Sodium Extended-release Tablets
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class III · Low risk
Diltiazem HCl CD capsules
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class II · Moderate risk
Ephedrine Sulfate
Lack of assurance of sterility.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Class III · Low risk
Clobetasol Propionate Emollient Cream 0.05%
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Class I · High risk
the silver bullet 10x Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Class II · Moderate risk
LET Gel 4%
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Class II · Moderate risk
BromSite (bromfenac ophthalmic solution)
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk
Alprazolam Tablets
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Class II · Moderate risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan and HydrochlorothiazideTablets
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag
Labeling: Label mix-up