Class I · High risk
Iohexol (300 mg Iodine/mL)
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
FDA Drug Recalls
1,293 recalls, newest first
Class I · High risk
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class I · High risk
Atenolol Tablets
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
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
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 III · Low risk
Nighttime Sleep-Aid
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class III · Low risk
Lamotrigine Tablets
Labeling: Label Error on Declared Strength
Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class II · Moderate risk
Alcohol Swabsticks
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Sterile Alcohol Prep Pads
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Racepinephrine Inhalation Solution
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Dakin's Solution
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
A&D Original Ointment
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Pataday
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
GenTeal Tears
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Miralax (Polyethylene Glycol 3350)
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Debrox
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane Zaditor
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Systane Balance
CGMP Deviations: products were stored outside the drug label specifications.
Class II · Moderate risk
Eye-stream
CGMP Deviations: products were stored outside the drug label specifications.