Class II · Moderate risk
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Lack of Processing Controls.
Class I · High risk
PeriGiene
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk
KleenFoam
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk
DermaSarra
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk
DermaKleen
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Class II · Moderate risk
Sucralfate Tablets
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
Shave and Skincare Power Stick Original Nourishing Invisible…
CGMP Deviations
Class II · Moderate risk
Beauty & Skincare Power Stick original nourishing invisible…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class III · Low risk
Fluorescein 2% Ophth
Subpotent Drug
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class II · Moderate risk
Cinacalcet Tablets 90 mg
Failed Dissolution Specifications.
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
Epinephrine Lidocaine HCL
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Rite Aid Pharmacy
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.