Class II · Moderate risk
Levonorgestrel Non-Micronized
cGMP Deviations; lack of quality assurance.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class II · Moderate risk
Ethinyl Estradiol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Testosterone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estrone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estriol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estradiol Non-Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estradiol Micronized Bulk
cGMP Deviations; lack of quality assurance.
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Failed Impurities/Degradation Specifications.
Class III · Low risk
Isopto Carpine
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class III · Low risk
CLENZIderm M.D. Acne Treatment System
Discoloration.
Class III · Low risk
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class III · Low risk
Fluocinonide Cream UPS
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Class II · Moderate risk
Latanoprost Ophthalmic Solution
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Class II · Moderate risk
Kalbitor (ecallantide)
Presence of Particulate Matter: Glass