Class II · Moderate risk
Fexofenadine Hydrochloride Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
FDA drug recalls in 2024
Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Lurasidone Hydrochloride Tablets 120mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Lurasidone Hydrochloride Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 80 mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Cinacalcet Tablets 60mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Adrenalin (epinephrine)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class II · Moderate risk
Fosfomycin Tromethamine Granules for Oral Solution
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Class II · Moderate risk
Hydrogen Peroxide Oral Rinse
CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk
OralProCare medicated lip treatment
CGMP Deviations: products may not conform to the labeled specifications.
Class II · Moderate risk
Phenoxybenzamine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class II · Moderate risk
Budesonide Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Subpotent Drug
Class II · Moderate risk
Rifampin Capsules USP
Failed Impurities/Degradation Specification.
Class II · Moderate risk
Vasostrict
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II · Moderate risk
Medline Remedy Clinical TREAT Antifungal Cream
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class II · Moderate risk
Fosaprepitant for Injection 150 mg per vial
Lack of Sterility Assurance: Aseptic process simulation failure.