Class II · Moderate risk
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Lack of Assurance of Sterility
FDA drug recalls in 2026
Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
563 recalls, newest first.
Class II · Moderate risk
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class III · Low risk
Lidocaine HCl Injection
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class III · Low risk
Pred Mild
Failed Stability Specifications
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class II · Moderate risk
VistaPharm
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
Duloxetine DR Capsules
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Class III · Low risk
Nicotine Transdermal System Patch
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Class I · High risk
DOXOrubin Hydrochloride Liposome injection
Presence of Particulate matter: Particulate matter identified as glass.
Class II · Moderate risk
Lidocaine HCl Injection USP
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate
Subpotent Drug
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Gas-X
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Class II · Moderate risk
cimzia (certolizumab pegol)
Lack of Assurance of Sterility
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class III · Low risk
Busulfan Injection
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Vitamin B-Complex
Presence of a Foreign Substance; black particles observed in liquid
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Atomoxetine Capsules HCL
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit