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.
FDA Drug Recalls
17,898 recalls, newest first
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
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 III · Low risk Ongoing
Fluorescein 2% Ophth
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.
Class III · Low risk Completed
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk Completed
Epinephrine Lidocaine HCL
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk Ongoing
Rite Aid Pharmacy
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
Good Neighbor Pharmacy
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
H-E-B
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
ReliOn
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
CURAD Alcohol Prep Pads
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
Medline Alcohol Prep Pads
Reason Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.