FDA Drug Recalls
778 recalls, newest first
Class II · Moderate risk Ongoing Aug 5, 2025
Reason Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class III · Low risk Ongoing Aug 5, 2025
Reason 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…
Class II · Moderate risk Ongoing Aug 5, 2025
Reason Presence of foreign substance: identified as aluminum.
Class II · Moderate risk Ongoing Aug 4, 2025
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing Aug 4, 2025
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Ongoing Aug 4, 2025
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk Ongoing Aug 4, 2025
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class II · Moderate risk Ongoing Jul 30, 2025
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk Ongoing Jul 30, 2025
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk Ongoing Jul 30, 2025
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class I · High risk Ongoing Jul 30, 2025
Reason Microbial Contamination of Sterile Products: elevated endotoxin levels
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing Jul 30, 2025
Reason Lack of Assurance of Sterility