Class I · High risk
Zicam Nasal Allclear
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
FDA Drug Recalls
231 recalls · Class I, newest first
Class I · High risk
Zicam Cold Remedy Medicated Nasal Swabs
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk
Sulfamethoxazole and Trimethoprim Tablets
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class I · High risk
Endurance Boost With Horny Goat Weed
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Class I · High risk
Ropivacaine Hydrochloride Injection
Presence of Particulate Matter
Class I · High risk
Male Ultra Pro
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Ultra Armor
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Electro Buzz
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Class I · High risk
Malextra
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Male Ultra
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class I · High risk
Vitality
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class I · High risk
BD ChloraPrep Clear 1mL Applicators
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Class I · High risk
POTASSIUM CHLORIDE Inj.
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Class I · High risk
Fentanyl Transdermal System CII
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class I · High risk
SinuCleanse Soft Tip NETI POT Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
SinuCleanse Premixed SALINE PACKETS
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk
Phenylephrine HCl Injection
Presence of Particulate Matter.
Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
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