Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
FDA Drug Recalls
900 recalls · Class II, newest first
Class II · Moderate risk
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class II · Moderate risk
Phenazopyridine HCl
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
Petroleum Jelly
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Class II · Moderate risk
Bicillin L-A
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
Infuvite Adult Multiple vitamins injection
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
Rocuronium Bromide Injection
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
Voriconazole for Oral Suspension
Labeling: Incorrect or Missing Package Insert
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Capsaicin Cream 0.025%
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II · Moderate risk
Sodium Fluoride 1.1%
Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II · Moderate risk
hello wild strawberry fluoride toothpaste
Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.
Class II · Moderate risk
Famotidine Tablets
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk
JARDIANCE (Empagliflozin)
Labeling: Label Mix-up
Class II · Moderate risk
Heparin Sodium Injection
Labeling: Not elsewhere classified
Class II · Moderate risk
Ganciclovir for Injection
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
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
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.