Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
FDA Drug Recalls
70 recalls · Class I, newest first
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk
Adrenalin Chloride Solution
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Class I · High risk
FOUZEE SugarLin HERBAL FORMULA capsules
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Class I · High risk
Nhan Sam Tuyet Lien Truy Phong Hoan
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Class I · High risk
FORCE FOREVER 400mg Tablets
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk
Clonazepam Orally Disintegrating Tablet
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk
ZapMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
ZoomMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
PeakMax Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
VitalityXtra Capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk
Ascorbic Acid Inj. Solution
Presence of Particulate Matter: Presence of glass particulates.
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Class I · High risk
Vail-Bon Jie Yang Wan capsules
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Class I · High risk
Atovaquone Oral Suspension
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter
Class I · High risk
Umary Acido Hialuronico
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk
Umary Acido Hialuronico
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk
Gold Hard Steel Plus Liquid
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
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.