Class II · Moderate risk Ongoing
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Quick Touch Alcohol Prep Pads
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Belsomra
Reason Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications: low dissolution results
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 I · High risk Ongoing
PeriGiene
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk Ongoing
KleenFoam
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk Ongoing
DermaSarra
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk Ongoing
DermaKleen
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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