Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class II · Moderate risk
Alcolado Relampago
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Yager's Liniment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Blis-To-Sol Liquid
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class III · Low risk
Pluvicto 1
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
Class I · High risk
Vegetal Vigra
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class II · Moderate risk
Rasagiline Tablets 0.5mg
Failed dissolution specifications - results obtained were below spec average.
Class II · Moderate risk
Helix CBD Clinical Cream
CGMP Deviations
Class II · Moderate risk
Helix CBD Therapy Cream
CGMP Deviations
Class II · Moderate risk
Helix Tri-Active Therapy Cream
CGMP Deviations
Class II · Moderate risk
Helix Pain Relieving Cream
CGMP Deviations
Class II · Moderate risk
Protex Foaming Hand Sanitizer
CGMP Deviations
Class III · Low risk
0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Class III · Low risk
Tobramycin Opthalmic Solution USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
Cromolyn Sodium Oral Solution
CGMP deviation: product released prior to supplier approval.
Class II · Moderate risk
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag
cGMP deviations: due to shipment of rejected units.
Class III · Low risk
Fosfomycin Tromethamine Granules for Oral Solution
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Class II · Moderate risk
morphine in 0.9% Sodium Chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
fentaNYL in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
rocuronium
Lack of assurance of sterility: Lack of validation data for sanitization cycles