Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
CUROSURF (poractant alfa)
Lack of Assurance of Sterility
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility