Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Labeling errors & mix-ups
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose.
1,411 FDA drug recalls with this cause, newest first.
This is exactly what it sounds like: the wrong label on the right product, the wrong strength printed on the bottle, a missing or illegible lot number and expiry date, or two products mixed up during packaging. It is dangerous precisely because the pill or liquid itself may be fine, yet the patient has no way of knowing what they are actually taking. A high share of the Class I recalls in this group are mix-ups where a stronger product ended up in a weaker product's packaging.
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 II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class III · Low risk
Crest 3D White Fluoride Anticavity Toothpaste
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
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.
Class II · Moderate risk
Systane
CGMP Deviations: products were stored outside the drug label specifications.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.