Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules USP
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
FDA Drug Recalls
1,563 recalls, newest first
Class III · Low risk
Oxytocin 30 Units added to NS 500 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 20 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk
Oxytocin 10 Units added to NS 1000 mL
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class II · Moderate risk
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Labeling: Incorrect expiration date.
Class II · Moderate risk
Moisturizing Lubricant Eye Drops
Failed Stability Specification: out of specification results for Sodium Perborate
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
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag
Labeling: Label mix-up