Class I · High risk Ongoing
Mojo Max Fusion XXX
Reason Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Reason Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class I · High risk Ongoing
Green Lumber Natural Fuel For Men capsule
Reason Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Class I · High risk Ongoing
Cyclobenzaprine Hydrochloride Tablets
Reason Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Class I · High risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter.
Class I · High risk Ongoing
Lactated Ringers's Injection USP
Reason Presence of Particulate Matter
Class I · High risk Ongoing
Nad+
Reason Microbial Contamination of Sterile Products: elevated endotoxin levels
Class I · High risk Ongoing
PeriGiene
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk Ongoing
KleenFoam
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk Ongoing
DermaSarra
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk Ongoing
DermaKleen
Reason Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk Ongoing
Buffered Penicillin G Potassium for Injection
Reason Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class I · High risk Ongoing
Cefazolin for Injection
Reason Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Class I · High risk Ongoing
Orajel Baby
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Class I · High risk Ongoing
Zicam Nasal Allclear
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk Ongoing
Zicam Cold Remedy Medicated Nasal Swabs
Reason Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Class I · High risk Ongoing
Sulfamethoxazole and Trimethoprim Tablets
Reason Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Class I · High risk Ongoing
Endurance Boost With Horny Goat Weed
Reason Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Class I · High risk Ongoing
Ropivacaine Hydrochloride Injection
Reason Presence of Particulate Matter
Class I · High risk Ongoing
Male Ultra Pro
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Ultra Armor
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Electro Buzz
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Class I · High risk Ongoing
Malextra
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Male Ultra
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Class I · High risk Ongoing
Levetiracetam 0.75% in Sodium Chloride Injection 1
Reason 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.