Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications: low dissolution results
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin injection solution
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Reason Lack of Processing Controls.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class II · Moderate risk Ongoing
Sucralfate Tablets
Reason CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II · Moderate risk Ongoing
Shave and Skincare Power Stick Original Nourishing Invisible…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Beauty & Skincare Power Stick original nourishing invisible…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Bicillin L-A
Reason CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk Ongoing
Bicillin L-A
Reason CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk Ongoing
Semaglutide
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Semaglutide
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Semaglutide
Reason Subpotent Drug
Class II · Moderate risk Ongoing
Cinacalcet Tablets 90 mg
Reason Failed Dissolution Specifications.