Class I · High risk
2% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
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 I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
4.2% Sodium Bicarbonate Injection
Presence of Particulate Matter: identified as glass.
Class II · Moderate risk
Foscarnet Sodium 2.4mg/0.1 mL solution for injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 4% ophthalmic solution
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium chloride Solution for Intravenous Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TPC Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Cefuroxime 4mg /0.4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin in Balanced Salt Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate 2.5% solution for inhalation
Lack of Assurance of Sterility
Class II · Moderate risk
Calcium Gluconate Ophthalmic Irrigation Solution 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Endophth Kit
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bevacizumab 1.25 MG/0.05 ML Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Restore Sinus Spray
Microbial contamination of Non-Sterile Products
Class II · Moderate risk
ION* Sinus Support Nasal Spray
Microbial contamination of Non-Sterile Products
Class I · High risk
ION*Sinus Spray
Microbial contamination of Non-Sterile Products
Class II · Moderate risk
Gynazole-1
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class II · Moderate risk
Triamcinolone Acetonide Injectable Suspension
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Class I · High risk
Brexafemme
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).