Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Class III · Low risk
Sensodyne PRONAMEL
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class II · Moderate risk
Spironolactone Tablets
Presence of foreign substance: identified as aluminum.
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk
Lactated Ringer's Injection USP
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk
4.2% Sodium Bicarbonate Injection
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class I · High risk
NAD+ (Nicotinamide adenine dinucleotide)
Microbial Contamination of Sterile Products: elevated endotoxin levels
Class II · Moderate risk
Retatrutide for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Lyophilized powder for reconstitution
Lack of Assurance of Sterility
Class II · Moderate risk
Epithalon for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tesamorelin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Thymosin Beta-4
Lack of Assurance of Sterility
Class II · Moderate risk
BPC-157/Thymosin Beta-4 for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BPC-157 for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide with B12 for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Saline Reconstitution Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Reconstitution XO Solution for Injection
Lack of Assurance of Sterility