Class I · High risk
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
FDA drug recalls in 2024
Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
Class I · High risk
Healthy Living Acetaminophen
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class I · High risk
Acetaminophen Injection
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Class II · Moderate risk
Lidocaine HCL Injection
Subpotent Drug: reduced efficacy for epinephrine
Class III · Low risk
Peg-3350
Defective container: potential for non-sealed pouches which can lead to product leakage.
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class II · Moderate risk
Decitabine for Injection 50mg per vial
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk
Pravastatin Sodium Tablets
Failed Dissolution Specifications: results below specifications
Class II · Moderate risk
Fludrocortisone Acetate Tablets
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class II · Moderate risk
Cyanocobalamin Injection
Presence of particulate matter: glass
Class II · Moderate risk
Infla-650 Herbal Dietary Supplement
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Class III · Low risk
Sevelamer Carbonate for Oral Suspension 0.8g packets
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class II · Moderate risk
Potassium Chloride Micro 10mEq K
CGMP Deviations: Out of specification for dissolution
Class II · Moderate risk
Blemfree All Day Lotion
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Class II · Moderate risk
Budesonide
CGMP Deviations and Presence of Particulate Matter: Glass
Class I · High risk
Potassium Chloride Extended-Release Capsules
Failed Dissolution Specifications
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Nature's Script CBD Cryotherapy Pain Relief Roll on
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class III · Low risk
Hemp Bombs CBD Pain Freeze
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.