Class II · Moderate risk
Rifampin Capsules
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Ampicillin for Injection
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class III · Low risk
oxyTOCIN 30 Units/500 mL
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class III · Low risk
Clonidine Hydrochloride Tablets
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Class III · Low risk
Xolegel (ketoconazole)
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class II · Moderate risk
Budesonide Inhalation Suspension 0.25mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Lisinopril 10 mg tablets
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class III · Low risk
Phytonadione Injectable Emulsion USP
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class I · High risk
Antica Farmacista Hand Sanitizer Ocean Citron
Chemical Contamination: product found to contain benzene
Class II · Moderate risk
Sanitizing Hand Spray 80%
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Triamcinolone Acetonide cream
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Synergy Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class III · Low risk
Antibacterial Foaming Wash with Hydria Moisturizing Formula
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Class II · Moderate risk
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QUAD-MIX 30/2/60/0.15 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 50/2.5/25 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/20 Injectable
Lack of Assurance of Sterility