FDA Drug Recalls
778 recalls, newest first
Class II · Moderate risk Terminated Jun 27, 2025
Reason Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…
Class III · Low risk Ongoing Jun 26, 2025
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Ongoing Jun 26, 2025
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Ongoing Jun 24, 2025
Reason Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH)…
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing Jun 20, 2025
Reason Subpotent Drug: Assay below the approved specification
Class II · Moderate risk Ongoing Jun 19, 2025
Reason Defective container; blister packaging inadequately sealed.
Class II · Moderate risk Ongoing Jun 19, 2025
Reason Defective container; blister packaging inadequately sealed.
Class III · Low risk Ongoing Jun 16, 2025
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Class II · Moderate risk Ongoing Jun 16, 2025
Reason Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability…
Class II · Moderate risk Ongoing Jun 16, 2025
Reason Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Class III · Low risk Ongoing Jun 11, 2025
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Ongoing Jun 11, 2025
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Ongoing Jun 11, 2025
Reason Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class II · Moderate risk Ongoing Jun 10, 2025
Reason Subpotent Drug
Class I · High risk Ongoing Jun 6, 2025
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I · High risk Ongoing Jun 6, 2025
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk Ongoing Jun 6, 2025
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class II · Moderate risk Ongoing Jun 2, 2025
Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.