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.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Subpotent Drug: Assay below the approved specification
Defective container; blister packaging inadequately sealed.
Defective container; blister packaging inadequately sealed.
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Subpotent Drug
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.