Class II · Moderate risk
Corlanor (ivabradine)
Presence of Foreign Substance.
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Gas-X Extra Strength
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class III · Low risk
Primidone Tablets
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Cura Hongos
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Rapidol
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lil Drug Store
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Circle K
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lucky Super Soft
CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Lucky Super Soft
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
Class II · Moderate risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class I · High risk
BEEKEEPER'S NATURALS Saline Nasal Spray
Microbial Contamination of Non-Sterile Products
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Minocycline Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis