Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective container; yellow colored spike from cap lodged in the nozzle
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Lidocaine HCL Injection
Subpotent Drug: reduced efficacy for epinephrine
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 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 II · Moderate risk
buPROPion Hydrochloride Extended-release Tablets USP
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
Little Moon Essentials
CGMP deviations
Class II · Moderate risk
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II · Moderate risk
Venlafaxine Hydrochloride
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II · Moderate risk
Methylphenidate Hydrochloride
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.